MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-09-12 for OLYMPUS CF-Q180AL manufactured by Olympus Medical Systems Corporation.
[950983]
The user facility reported that during a diagnostic colonoscopy, a complete loss of image was experienced. The procedure was reportedly completed with a similar, but different device and there was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
[8096983]
The device referenced in this report was returned to olympus for investigation. The investigation confirmed the user's report of a complete loss of image. There was evidence of fluid inside the light guide cover glass and corrosion noted in the endoscope connector, electrical connector, and the light guide bundle, which most likely caused the user's experience. Additionally, the distal end cover was found cracked and there was a long, deep scratch on the insertion tube at the 30cm mark and the unit failed electrical leakage testing. The bending section mesh contained frayed wires and there was play in the angulations control knobs. As the device passed the leak test, the source of a fluid invasion appears to be due to physical damage and/or mishandling. This report is being submitted as a medical device report in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2008-00159 |
| MDR Report Key | 1170009 |
| Report Source | 05,06 |
| Date Received | 2008-09-12 |
| Date of Report | 2008-08-14 |
| Date of Event | 2008-08-13 |
| Date Added to Maude | 2009-02-18 |
| 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 II COLONOVIDEOSCOPE |
| Product Code | FTJ |
| Date Received | 2008-09-12 |
| 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 | SHINJUKU-KU 1-CHOME TOKYO JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-09-12 |