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
General & plastic surgery laparoscope - Product Code GCJ
원인
The coupler on this device was manufactured without set-screws that are used to hold and center the rear assembly and the endobody. the coupler is part of the camera system and affects the ability to focus.
조치
Only one customer had all of the defective couplers. The firm called this customer on March 27, 2008, and asked that the 28 couplers remaining in their possession be returned.
24mm Rotating C-Mount Coupler, Model Number 1088-020-121S2. The device in indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope, endoscope or arthroscope is indicated for use.