MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06 report with the FDA on 2008-10-13 for OLYMPUS CF-Q180AL manufactured by Olympus Medical Systems Corporation.
[979861]
The user facility reported that during a diagnostic colonoscopy, the image was lost and could not be recovered. The procedure was completed with a similar, but different device, and no patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[8229449]
The device referenced in this report was returned to olympus for investigation. The investigation could not confirm the user's claim of a complete image loss, however, image was noted, and fluid was located inside the endoscope connector. There were dents and scratches noted on the distal end cover, damage to the objective lens, light-guide lenses, and all of the switches were noted to be malfunctioning. Additionally, the bending section rubber was noted to be in poor condition. The fluid invasion contributed to the image and switch difficulties. The cause of the fluid invasion could not conclusively determined, however, user handling is likely, as the unit passed leak testing. This report is being filed as a medical device report in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2008-00172 |
| MDR Report Key | 1207942 |
| Report Source | 00,05,06 |
| Date Received | 2008-10-13 |
| Date of Report | 2008-09-19 |
| Date Added to Maude | 2009-03-17 |
| 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 |
| Manufacturer G1 | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Street | 22-2 NISHI-SHINJUKU SHINJUKU-KU, 1-CHOME |
| Manufacturer City | TOKYO 163-91 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 163-91 |
| 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 | 2008-10-13 |
| Model Number | CF-Q180AL |
| 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 | SHINJUKU-KU, 1-CHOME |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-10-13 |