MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-08-28 for OLYMPUS URETERO-RENO VIDEOSCOPE URF-V manufactured by Olympus Medical System Corporation.
[3115492]
The user facility reported that during a diagnostic cystoscopy procedure the users experienced a total loss of image. There was no pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
[10105332]
The device referenced in this report was returned to olympus for eval. The eval confirmed the user's report. The device produced no image and horizontal lines appeared on the video screen while the device was being tested. There was evidence of fluid invasion in the scope connector, and video connector, which caused the printed circuit board to become wet and caused the image difficulty. There was a large dent on the insertion tube. The device was refurbished.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2012-00310 |
| MDR Report Key | 2736855 |
| Report Source | 06 |
| Date Received | 2012-08-28 |
| Date of Report | 2012-07-31 |
| Date Mfgr Received | 2012-07-31 |
| Date Added to Maude | 2012-11-14 |
| 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 AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4848965688 |
| Manufacturer G1 | OLYMPUS MEDICAL SYSTEM 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 URETERO-RENO VIDEOSCOPE |
| Generic Name | URETEROSCOPE |
| Product Code | GCQ |
| Date Received | 2012-08-28 |
| Returned To Mfg | 2012-07-31 |
| Model Number | URF-V |
| Catalog Number | URF-V |
| 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 SYSTEM CORPORATION |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOYKO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-28 |