MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2007-10-12 for OLYMPUS CF-Q160AL manufactured by Olympus Medical Systems Corporation.
[691057]
The user facility reported that during a colonoscopy, there was an unclear video image with lines displayed across the video monitor which obstructed the image. The users attempted to manipulate the device, but was unable to retrieve the video image. The procedure was completed with a different, but similar device. There was no patient injury and no further information was provided.
Patient Sequence No: 1, Text Type: D, B5
[7877164]
The device referenced in this report was returned to olympus for investigation. The investigation initially confirmed a flickering video image, which later became distorted after extended testing. There was evidence of fluid invasion in both the electrical connector and endoscope connector. Additionally, corrosion was noted in the endoscope connector. The fluid invasion appears to have damaged charge coupler device (ccd) unit, and resulted in the image phenomena. The source of the fluid invasion appears to be due to user error as the device passed the leak test. This report is being filed as an mdr in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2007-00153 |
| MDR Report Key | 927551 |
| Report Source | 00,06 |
| Date Received | 2007-10-12 |
| Date of Report | 2007-09-14 |
| Date of Event | 2007-09-01 |
| Date Added to Maude | 2007-12-07 |
| 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 | EVIS EXERA COLONOVIDEOSCOPE |
| Product Code | FTJ |
| Date Received | 2007-10-12 |
| Model Number | CF-Q160AL |
| 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 | 929045 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Address | SHINJUKU-KU, 1-CHOME TOKYO JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-10-12 |