MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-07-24 for OLYMPUS CF-Q180AL manufactured by Olympus Medical Systems Corporation.
[884949]
The user facility reported that at the beginning of two different colonoscopy procedures, when the device was being inserted into the patient, the image froze and visualization was lost. Both procedures were reportedly completed with a similar, but different device. There were no patient injuries reported and no further information was provided.
Patient Sequence No: 1, Text Type: D, B5
[8076348]
The device referenced in this report was returned to olympus for investigation. The investigation confirmed the user's report of the image difficulty. The image was found flickering and the remote switches were noted to work intermittently. There was corrosion found inside the endoscope connector and extensive corrosion in the electrical connector. The cause for the user's experience was determined to be due to fluid invasion. As the device passed leak testing, the source of the fluid invasion appears to have been due to user mishandling. 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 | 8010047-2008-00128 |
| MDR Report Key | 1082788 |
| Report Source | 05,06 |
| Date Received | 2008-07-24 |
| Date of Report | 2008-06-26 |
| Date Added to Maude | 2008-10-23 |
| 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 COLONVIDEOSCOPE |
| Product Code | FTJ |
| Date Received | 2008-07-24 |
| Model Number | CF-Q180AL |
| Lot Number | NA |
| 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 | 1219500 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Address | SHINJUKU-KU, 1-CHOME TOKYO JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-07-24 |