Events

Device Recall 5X300 MM Curved Cannula, Arm 2 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Intuitive Surgical, 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
    67758
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1333-2014
  • 사례 시작날짜
    2014-03-13
  • 사례 출판 날짜
    2014-04-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-09-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126238
  • 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
    System,surgical,computer controlled instrument - Product Code NAY
  • 원인
    Intuitive surgical has become aware of the potential for certain lots of the single-site 5mm curved cannulae to become damaged during use. the second part of this action is to update single-site labeling. these labeling changes instruct users how to inspect cannulae prior to use and to appropriately handle cannulae during use.
  • 조치
    Intuitive sent an Urgent Medical Device letter dated March 25, 2014, to all users of cannulas that have the potential to be damaged during use as well as a second letter to all single site cannula users that provided clarity to instruction for use for inspections and handling of the product. Certain lots manufactured prior to August of 2012, and users were asked to use Attachment A to help identify affected lots numbers. Phase 1 - Cannulas should then be inspected with information provided in Attachment B. Any damaged devices should be quarantined and returned to intuitive. If inspection does not find damage, the device may continue to be used. Any other cannulae and any non damaged product should be used according to Attachment C's instructions for use. Phase 2 - Once replacement cannulae are available, the undamaged cannulae should be returned. The Acknowledgement form should be completed and returned to Intuitive. Intuitive will contact consignees when replacement cannulae are available. Questions should be directed to Customer Service at 800-876-1310. Those consignees that use the 5 mm canulae but do not have affected product were provided with a letter that only includes the Single Site Cannula inspection and Use addendum.

Device

Device Recall 5X300 MM Curved Cannula, Arm 2
  • 모델명 / 제조번호(시리얼번호)
    Part number 428062-03: Lot numbers:  VE105003 VE120304 VE121402 VE121903 VE122704 VE123101 VE111202 VE120402 VE121502 VE121905 VE122705 VE123103 VE114502 VE120504 VE121506 VE122201 VE122707 VE123105 VE114602 VE120902 VE121512 VE122202 VE122903 VE115202 VE121003 VE121606 VE122303 VE123005 VE120202 VE121113 VE121702 VE122501 VE123012.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA and the countries of Australia, Belgium, Brazil, Chile, China, Columbia, Denmark, France, Germany, India, Italy, Lebanon, Monaco, Netherlands, Norway, Romania, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Turkey and United Kingdom.
  • 제품 설명
    5X300 MM Curved Cannula, Arm 2 || for use with daVinci SI Surgical System, model number IS3000. || Intuitive Surgical || 1266 Kifer Road || Sunnyvale, CA 94086 || The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation,clip- ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators,monopolar cautery, bipolar cautery, 5mm curved cannulae,5mm and 10 mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port.
  • Manufacturer
    Intuitive Surgical, Inc.

Manufacturer

Intuitive Surgical, Inc.
  • 제조사 주소
    Intuitive Surgical, Inc., 1266 Kifer Rd Bldg 100, Sunnyvale CA 94086-5304
  • 제조사 모회사 (2017)
    Intuitive Surgical Inc
  • Source
    USFDA