MalfunctionFEJ
OLYMPUS
Received Oct 12, 2000
Report 9610773-2000-00036 · MDR key 300376
Device
Generic name
Video Laparoscope
Manufacturer
Olympus Winter & Ibe GmbhModel number
A4801ACatalog number
NA
Lot number
NA
Product problems
- No Display/Image
- Failure, intermittent
- Image Display Error/Artifact
Patient
UNKNOWN
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
AN OLYMPUS SALES REP REPORTED INTERMITTENT LOSS OF IMAGE DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE SAME VIDEO LAPAROSCOPE AND THERE NO INJURIES RELATED TO THE OCCURRENCE.
Remedial action
- Notification
- Modification/Adjustment