Events

Device Recall Precision Bipolar Device ClearGlide EVH 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Datascope Corporation 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
    38005
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1156-2007
  • 사례 시작날짜
    2007-05-07
  • 사례 출판 날짜
    2007-08-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-03-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52708
  • 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
    endoscopic vessel harvesting system - Product Code GEI
  • 원인
    Datascope has experienced a higher than usual number of reports involving the precision bipolar device. reports include the locking or sticking of the buttons of the device which operate the jaws, particularly when a side load is placed on the shaft of the device.
  • 조치
    Letters were sent to all hospitals, (contact: Hospital Administrators) the week of May 7, 2007 (certified mail, Return Receipt requested) with Urgent Medical Device Field Correction. The letter requests that all potential users of the devices at the institution be mdae aware of the situation. The letter instructs clinicians what to do if they experience problems with locking buttons of the Precision Device and also if the device is clamped closed on a vein branch and cannot be opened. Institutions are also requested to sign and return a postal card acknowledging receipt of the Field Correct notification and Datascope provides telephone numbers for customer service.

Device

Device Recall Precision Bipolar Device ClearGlide EVH
  • 모델명 / 제조번호(시리얼번호)
    Part number KTV 15 Lot numbers: 12499, Exp. 4/21/09; 12500, Exp. 4/22/09; 12501, Exp. 4/27/09; 12504, Exp. 5/04/09 and 12505, Exp. 5/13/09.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide, including USA, Belgium, the Netherlands, and Germany.
  • 제품 설명
    Precision Bipolar Device || ClearGlide EVH Small (endoscopic vessel harvesting system) || The kit included three Precision BiPolar Devices, an Optical Vessel Dissector, a Small Ultra Retractor and a Vessel Dissector. || Datascope Cardiac Assist || Sterile R || Manufactured for: || Datascope Cardiac Assist || 15 Law Drive || Fairfield, NJ 07004
  • Manufacturer
    Datascope Corporation

Manufacturer

Datascope Corporation
  • 제조사 주소
    Datascope Corporation, 15 Law Dr, Fairfield NJ 07004-0011
  • 제조사 모회사 (2017)
    Getinge AB
  • Source
    USFDA