MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-05-18 for OLYMPUS EVIS EXERA COLONOVIDEOSCOPE CF-Q160AL manufactured by Olympus Medical Systems Corporation.
[2659230]
The user facility reported that during a diagnostic colonoscopy the users experienced a complete loss of image. The colonoscope was withdrawn from the pt and the procedure was completed using a different but similar endoscope. There was no pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
[9888070]
The device referenced in this report was returned to olympus for eval. The eval did not confirm the user's report of image loss; however, there was evidence of fluid invasion in the electrical connector, scope connector, and control body unit, which likely caused the image difficulty. The device passed the leak test. The bending section cover and bending section cover glue are found to be a non-olympus repairs. The objective lens was cracked. The switch #1 button is not working. The insertion tube failed the insulation test. The device was refurbished. This report is being submitted as a medical device report in an excess of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2012-00159 |
| MDR Report Key | 2588945 |
| Report Source | 06 |
| Date Received | 2012-05-18 |
| Date of Report | 2012-04-20 |
| Date of Event | 2012-04-01 |
| Date Mfgr Received | 2012-04-20 |
| Date Added to Maude | 2012-06-15 |
| 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 | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 192-8507 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS EVIS EXERA COLONOVIDEOSCOPE |
| Generic Name | COLONOSCOPE |
| Product Code | FTJ |
| Date Received | 2012-05-18 |
| Returned To Mfg | 2012-04-20 |
| Model Number | CF-Q160AL |
| Catalog Number | CF-Q160AL |
| Lot Number | NA |
| ID 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 | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-05-18 |