MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2012-08-01 for OLYMPUS URETERO-RENO VIDEOSCOPE URF-V manufactured by Olympus Medical Systems Corporation.
[2866553]
Olympus was informed that the images went completely out. The image flickered during the first procedure but went completely out during the second procedure. There was no pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
[10122446]
Olympus followed-up with the user facility to obtain add'l info regarding this report, but no further detail was provided. The device referenced in this report was returned to olympus for eval. The eval confirmed the user's report. The image was flickering intermittently and blacked out due to fluid invasion. The control body was noted with corrosion and fluid invasion. The switch buttons 1-4 were not functioning and there was a cut noted on the bending section. There was a leakage observed from the bending cover. Additionally, the internal angulation wires were damaged. The reported phenomena were attributed to mishandling.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2012-00242 |
| MDR Report Key | 2700475 |
| Report Source | 06,07 |
| Date Received | 2012-08-01 |
| Date of Report | 2012-07-03 |
| Date Mfgr Received | 2012-07-03 |
| Date Added to Maude | 2012-09-26 |
| 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 | 3 |
| 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 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 URETERO-RENO VIDEOSCOPE |
| Generic Name | URETEROSCOPE |
| Product Code | GCQ |
| Date Received | 2012-08-01 |
| Returned To Mfg | 2012-07-06 |
| 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 SYSTEMS CORPORATION |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-01 |