MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-11-21 for OLYMPUS CF-140L manufactured by Olympus Medical Systems Corporation.
[994463]
The user facility reported that during a diagnostic colonoscopy, a metal piece at the distal end of the endoscope created a "rip with a flap" on the mucosa of the pt's colon. Other minor trauma was said to be noted, but no specific details were provided. The facility has been contacted by both phone and in writing for additional info, however, no additional info has been provided.
Patient Sequence No: 1, Text Type: D, B5
[8132805]
The device referenced in this report was returned to olympus for eval. The eval did not duplicate the user's report of sharp distal end. The distal end cover was noted to be cracked, but there was no sharp surfaced detected. The air/water nozzle was checked and found to be in good condition. The unit was noted to fail both air and electrical leakage testing due to the crack in the distal end cover. , there were tiny chips and old glue found around the objective and light guide lenses, but no areas of sharpness detected at these locations. The cause of the pt's outcome cannot conclusively be determined. The device has been serviced and returned to the user facility. This report is being submitted as an mdr in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2008-00195 |
| MDR Report Key | 1241520 |
| Report Source | 05,06 |
| Date Received | 2008-11-21 |
| Date of Report | 2008-10-29 |
| Date Mfgr Received | 2008-10-29 |
| Date Added to Maude | 2009-01-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LAURA STORMS-TYLER |
| Manufacturer Street | 2400 RINGWOOD AVE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4848965688 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS |
| Generic Name | COLONOSCOPE |
| Product Code | FTJ |
| Date Received | 2008-11-21 |
| Model Number | CF-140L |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Address | SHINJUKI-KU, 1-CHOME TOKYO JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-11-21 |