D
Patient 1
THE USER FACILITY REPORTED THAT DURING A DIAGNOSTIC COLONOSCOPY, A COMPLETE LOSS OF IMAGE WAS EXPERIENCED. THE PROCEDURE WAS REPORTEDLY COMPLETED WITH A SIMILAR, BUT DIFFERENT DEVICE AND THERE WAS NO PATIENT INJURY.
MAUDE MDR 1170009
- MDR report key
- 1170009
- Report number
- 8010047-2008-00159
- Event key
- 0
- Event type
- 3
- Date of event
- 2008-08-13
- Date received
- 2008-09-12
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- LAURA STORMS-TYLER
- Address
- 2400 RINGWOOD AVE. SAN JOSE CA 95131 US
- Phone
- 484-484-4848
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | OLYMPUS | EVIS EXERA II COLONOVIDEOSCOPE | OLYMPUS MEDICAL SYSTEMS CORPORATION | FTJ | CF-Q180AL | NA | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2008-09-12 | 0 |
Event Narratives#
N
Patient 1
THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR INVESTIGATION. THE INVESTIGATION CONFIRMED THE USER'S REPORT OF A COMPLETE LOSS OF IMAGE. THERE WAS EVIDENCE OF FLUID INSIDE THE LIGHT GUIDE COVER GLASS AND CORROSION NOTED IN THE ENDOSCOPE CONNECTOR, ELECTRICAL CONNECTOR, AND THE LIGHT GUIDE BUNDLE, WHICH MOST LIKELY CAUSED THE USER'S EXPERIENCE. ADDITIONALLY, THE DISTAL END COVER WAS FOUND CRACKED AND THERE WAS A LONG, DEEP SCRATCH ON THE INSERTION TUBE AT THE 30CM MARK AND THE UNIT FAILED ELECTRICAL LEAKAGE TESTING. THE BENDING SECTION MESH CONTAINED FRAYED WIRES AND THERE WAS PLAY IN THE ANGULATIONS CONTROL KNOBS. AS THE DEVICE PASSED THE LEAK TEST, THE SOURCE OF A FLUID INVASION APPEARS TO BE DUE TO PHYSICAL DAMAGE AND/OR MISHANDLING. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.