| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | OLYMPUS | COLONOSCOPE | OLYMPUS MEDICAL SYSTEMS CORPORATION | FTJ | PCF-160AL | NA | N | R | Y |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2007-09-21 | 0 |
Patient 1
THE USER FACILITY REPORTED THAT DURING A DIAGNOSTIC COLONOSCOPY, PINK AND RED LINES APPEARED ON THE VIDEO SCREEN RESULTING IN IMAGE LOSS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT, BUT SIMILAR DEVICE. THERE WAS NO PATIENT INJURY REPORTED.
Patient 1
THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR INVESTIGATION. THE INVESTIGATION CONFIRMED THE USER'S REPORT OF FLICKERING WITH STATIC AND LINES ON THE DISPLAY. THERE WERE THIRD PARTY REPAIRS NOTED ON THE LIGHT GUIDE TUBE, ELECTRICAL CONNECTOR AND BURNDY PIN. THERE WERE SEVERE DENTS AND CRACKS OBSERVED ON THE DISTAL TIP PLASTIC COVER (C-COVER), WHICH CAUSED THE DEVICE TO FAIL THE INSULATION TEST. THERE WAS CORROSION FOUND INSIDE THE ENDOSCOPE CONNECTOR (S-CONNECTOR), INDICATING FLUID INVASION, WHICH APPEARS TO BE DUE TO USER HANDLING AS THE DEVICE PASSED LEAK TESTING. THE DEVICE WAS TESTED WITH A TEMPORARY ELECTRICAL CONNECTOR AND THE VIDEO IMAGE WAS FOUND TO BE APPROPRIATE. THE IMAGE DIFFICULTY WAS ISOLATED TO THIRD PARTY REPAIRS AND FLUID INVASION. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER. ADDITIONAL COMMENTS: THE PCF-160AL ADVISES USERS THAT THE DEVICE SHOULD ONLY BE SERVICED BY OLYMPUS TECHNICIANS.