inforMED
MalfunctionLMB

OLYMPUS

Received Oct 8, 2008 · Event occurred Sep 8, 2008

Report 3006219967-2008-00002 · MDR key 1196980

Device

Generic name

Endoworks

Model number

EW 7.3.7

Catalog number

HW101-102

Product problems

  • Image Resolution Poor
  • Repair

Patient

UNK

  • Surgery, prolonged

Narrative

Description of Event or Problem

IT WAS REPORTED IN 2008 BY THE CUSTOMER THAT WHEN ENTERING IMAGE CAPTURE MODE, THE VIDEO DISPLAY SHOWED A DOUBLE BLURRY IMAGE. THE CUSTOMER REBOOTED THE COMPUTER AND THE BIOMED SWAPPED OUT THE VIDEO MONITORS AND CABLES. THE BIOMED SWAPPED OUT VIDEO CARTS SO THAT THE CUSTOMER COULD FINISH THE PROCEDURE. CUSTOMER STATED THAT THE PT WAS UNDER ANESTHESIA FOR A PROLONGED PERIOD OF TIME. THE CUSTOMER WAS CONTACTED BY OLYMPUS AND WE WERE UNABLE TO DETERMINE THE ADDITIONAL PERIOD OF TIME, HOWEVER, NO PT INJURY WAS REPORTED.

Additional Manufacturer Narrative

AN INVESTIGATION IS CURRENTLY BEING CONDUCTED, AND OLYMPUS HAS BEEN ABLE TO CONFIRM THAT THIS REPORTED PROBLEM MAY OCCUR ONLY WHEN THE USER INITIATES IMAGE CAPTURE AFTER A SYSTEM REBOOT. IF THE USER EXITS THE IMAGE CAPTURE MODE AND REENTERS THIS MODE, THE IMAGE PROBLEM DISAPPEARS. THE HOSPITAL HAS BEEN INSTRUCTED TO SET ENDOWORKS TO "SCOPE MODE" AND TO NOT TO USE ENDOWORKS "PC MODE" AS THIS ELIMINATES ANY POTENTIAL IMPACT ON THE LIVE IMAGE DISPLAY. A ROOT CAUSE INVESTIGATION IN STILL IN PROGRESS.