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 2008-09-19 for OLYMPUS CF-Q180AL manufactured by Olympus Medical Systems Corporation.
[924596]
The user facility reported that during a diagnostic colonoscopy the image was lost, and could not be recovered. The procedure was completed with a different, but similar device. There was no allegation of patient injury.
Patient Sequence No: 1, Text Type: D, B5
[8096581]
The device referenced in this report was returned to olympus for investigation. The investigation confirmed the user's claim of image loss. There was evidence of extensive fluid invasion and corrosion inside the endoscope connector and electrical connectors. There was a leak noted at the water supply connector, however, based upon the location of the fluid invasion, it appeared that the majority of the fluid invaded the device when it was reprocessed without a securely seated water resistant cap. The loss of image was isolated to the flexible printed circuit board, which was damaged due to the fluid invasion. The investigation also noted damage to the bending section, bending section cement, a cracked objective lens, buckles and chemical damage to the insertion tube, and cuts and scratches on the light guide tube. This report is being fled as a medical device report in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2008-00161 |
| MDR Report Key | 1172635 |
| Report Source | 00,05,06 |
| Date Received | 2008-09-19 |
| Date of Report | 2008-08-25 |
| Date Added to Maude | 2009-02-03 |
| 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 |
| Reporter Occupation | MEDICAL ASSISTANT |
| 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 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 | 2008-09-19 |
| Model Number | CF-Q180AL |
| 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 | 1-CHOME SHINJUKU-KU JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-09-19 |