Events

Device Recall Olympus Electrosurgical Unit (ESG100) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Olympus America Inc. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    60548
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0747-2012
  • 사례 시작날짜
    2011-11-28
  • 사례 출판 날짜
    2012-01-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-03-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105783
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • 원인
    Investigations of customer complaints revealed a counterfeit capacitor was used in the manufacture of some lots of the esg-100.
  • 조치
    Olympus America Inc. sent an URGENT: MEDICAL DEVICE CORRECTION ACTION" letter dated November 28, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use of the affected product. A questionnaire was attached to the letter for customers to complete and return via fax at 484-896-7128. Contact the firm at 484-896-5000 for questions regarding this notice.

Device

Device Recall Olympus Electrosurgical Unit (ESG100)
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers 11053P230001, 11053P230002, 11053P230003, 11053P230004, 11053P230005, 11060P230001, 11160P230002, 11060P230003, 11160P230004, 11160P230005, 11081P230001, 11081P230003, 11081P230004, 11081P230005, 11081P230006, 11081P230007, 11081P230008, 11081P230009, 11081P230010, 11094P230006, 11094P230007, 11094P230008, 11094P230009, 11094P230010, 11096P230007, 11096P230008, 11096P230009, 11096P230010, 11102P230001, 11102P230002, 11102P230003, 11102P230004, 11102P230005, 11109P230002, 11109P230003, 11109P230004, 11109P230005, 11110P230001, 11110P230002, 11110P230003, 11110P230004, 11110P230005, 11116P230001, 11116P230002, 11116P230003, 11116P230004, 11116P230005, 11117P230001, 11117P230002, 11117P230003, 11117P230004, 11117P230005, 11132P230001, 11132P230002, 11132P230003, 11132P230004, 11132P230005, 11133P230001, 11133P230002, 11133P230003, 11138P230002, 11138P230003, 11138P230004, 11139P230001, 11139P230002, 11139P230005, 11167P230001, 11167P230004, 11180P230003, 11180P230005, 11201P230005, 11201P230010, 11202P230001, 11202P230005, 25456W23-101, 25456W23-102, 25456W23-107, 25456W23-108, 25456W23-109, 25522W23-101, 25522W23-102, 25522W23-103, 25522W23-104, 25522W23-105, 25553W23-105, 25553W23-107, 25553W23-108, 25553W23-109, 25553W23-110, 25565W23-102, 25565W23-103, 25565W23-105, 25565W23-106, 25565W23-108, 25565W23-109, 25565W23-110, 25593W23-101, 25593W23-102, 25593W23-103, 25593W23-104, 25593W23-105, 25593W23-107, 25593W23-109, 25593W23-110, 25607W23-101, 25607W23-102, 25607W23-103, 25607W23-104, 25607W23-105, 25607W23-106, 25607W23-107, 25607W23-108, 25607W23-110, 25613W23-101, 25613W23-102, 25613W23-103, 25613W23-104, 25613W23-105, 25613W23-106, 25613W23-107, 25613W23-108, 25613W23-109, 25613W23-110, 25686W23-102, 25719W23-105, 25719W23-106, 25736W23-101, 25736W23-102, 25736W23-103, 25736W23-104, 25736W23-105, 25736W23-106, 25736W23-107, 25736W23-108, 25736W23-109, 25752W23-101, 25752W23-102, 25752W23-103, 25752W23-104, 25752W23-105, 25752W23-106, 25752W23-107, 25776W23-101, 25776W23-102, 25776W23-103, 25776W23-105, 25776W23-106, 25776W23-107, 25776W23-108, 25776W23-109, 25776W23-110, 25869W23-101, 25869W23-102, 25869W23-103, 25869W23-104, 25869W23-105, 25869W23-106, 25869W23-107, 25869W23-108, 25869W23-109, 25869W23-110, 25978W23-104, 25978W23-105, 25978W23-106, 25978W23-107, 26052W23-109, 26052W23-110, 26085W23-101, 26085W23-102, 26085W23-103, 26085W23-104, 26085W23-105, 26085W23-106, 26085W23-107, 26085W23-108, 26085W23-109, 26136W23-101, 26136W23-103, 26136W23-104, 26136W23-105, 26136W23-107, 26136W23-108, 26136W23-109, 26136W23-110, 26162W23-108, 26162W23-109, 26162W23-110, 26227W23-102, 26227W23-103, 26227W23-104, 26227W23-105, 26227W23-106, 26227W23-107, 26227W23-108, 26227W23-109, 26227W23-110, 26456W23-101, 26456W23-102, 26456W23-103, 26456W23-104, 26456W23-105, 26456W23-106, 26456W23-107, 26456W23-108, 26456W23-109, 26456W23-110, 26559W23-101, 26559W23-103, 26559W23-104, 26559W23-105, 26559W23-108, 26559W23-109, 26559W23-110, 26710W23-108, 26710W23-109, 26770W23-101, 26770W23-102, 26770W23-103, 26770W23-104, 26770W23-105, 26770W23-106, 26770W23-107, 26770W23-108, 26770W23-109, 26770W23-110, 26878W23-101, 26878W23-102, 26878W23-103, 26878W23-104, 26878W23-105, 26879W23-102, 26879W23-103, 26879W23-104, 26879W23-105, 26917W23-101, 26917W23-102, 26917W23-103, 26917W23-105, 26917W23-106, 26917W23-107, 26917W23-108, 26917W23-109, 26917W23-110, and 26992W23-110.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution.
  • 제품 설명
    Olympus Electrosurgical Unit. || The Olympus Electrosurgical Unit (ESG-100) is used in conjunction with cutting and coagulation electrosurgical devices intended for use in electrosurgery procedures during flexible gastrointestinal endoscopy.
  • Manufacturer
    Olympus America Inc.

Manufacturer

Olympus America Inc.
  • 제조사 주소
    Olympus America Inc., 3500 Corporate Pkwy., P.O. Box 610, Center Valley PA 18034-0610
  • 제조사 모회사 (2017)
    Olympus Corporation
  • Source
    USFDA