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 2007-11-21 for OLYMPUS CF-Q180AL manufactured by Olympus Medical Systems Corporation.
[739629]
The user facility reported that during a diagnostic colonoscopy, the video image was lost and could not be recovered. The procedure was completed with a different, but similar device and there was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
[7896385]
The device referenced in this report was returned to olympus for investigation. The investigation did not duplicate the user's report of the video image loss. The device was tested for several hours with different light sources and video processors without any video image difficulties. However, there was evidence of fluid and corrosion stains around the rim of the endoscope connector and electrical connector, which may have caused or contributed to the user's experience. In addition, there were scratches found on the distal end cover and a small cut on the bending section cover. As the device passed leak testing, user handling may have caused or contributed to the fluid invasion. This report is being filed as an mdr in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2007-00189 |
| MDR Report Key | 951797 |
| Report Source | 00,05,06 |
| Date Received | 2007-11-21 |
| Date of Report | 2007-10-24 |
| Date of Event | 2007-10-18 |
| Date Added to Maude | 2008-01-28 |
| 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-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 | EVIS EXERA II COLONOVIDEOSCOPE |
| Product Code | FTJ |
| Date Received | 2007-11-21 |
| Model Number | CF-Q180AL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 947377 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Address | SHINJUKU-KU 1-CHOME TOKYO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-11-21 |