| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | OLYMPUS ENDOSCOPES | ENDOSCOPES | OLYMPUS MEDICAL SYSTEM CORPORATION | GDB | UNK | UNK | NA | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2011-02-08 | 0 | 1. H |
Patient 1
OLYMPUS WAS INFORMED OF A MEDIA REPORT THAT ALLEGED THAT A USER FACILITY FAILED TO FULLY DISINFECT AN UNIDENTIFIED MODEL OF ENDOSCOPE THAT HAD BEEN USED ON FOUR PREVIOUS PTS. A PT WAS SAID TO BE UNDERGOING SEVERAL ROUNDS OF TESTING FOR SEXUALLY TRANSMITTED DISEASES.
Patient 1
OLYMPUS CONTACTED THE USER FACILITY TO OBTAIN ADD'L INFO REGARDING THIS REPORT. THE USER FACILITY REPORTED THAT THEY WERE UNSURE OF WHICH TYPE OF ENDOSCOPES WERE INVOLVED, HOWEVER, REVIEW OF INSTRUMENT HISTORY NOTED THAT THIS USER FACILITY HAD SEVERAL DIFFERENT TYPES OF OLYMPUS ENDOSCOPES. THERE WERE NO REPORTS OF INFECTIONS. THE USER FACILITY STATED THAT ANOTHER COMPANY'S TECH HAD INADVERTENTLY DE-PROGRAMMED THE DISINFECTANT CYCLE IN THE FACILITY'S AUTOMATIC ENDOSCOPE REPROCESSOR (AER). A TOTAL OF 11 SCOPES HAD BEEN REPROCESSED WITH THE DISINFECTANT CYCLE TURNED OFF. THE USER FACILITY CLAIMED THAT THEIR ENDOSCOPES UNDERWENT AN EXTENSIVE MANUAL REPROCESSING PRIOR TO BEING PLACED IN THE AER. PTS WHO HAD RECEIVED THE EXAM WITH THE DEVICE FULLY DISINFECTED AND PTS THAT WERE EXAMINED WITH THE DEVICE THAT HAD NOT RECEIVED THE DISINFECTANT CYCLE WERE NOTIFIED AND ALL WERE REQUESTED TO HAVE TESTING PERFORMED. IT WAS UNK WHETHER THERE WAS ANY CULTURES PERFORMED ON THE ENDOSCOPES. OLYMPUS HAS REQUESTED ADD'L INFO REGARDING THIS EVENT, HOWEVER, NO FURTHER INFO HAS BEEN PROVIDED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.