MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2012-10-19 for OLYMPUS URETERO-RENO VIDEOSCOPE URF-V manufactured by Olympus Medical Systems Corporation.
[3029928]
The user facility reported that during a transurethral ureterolithotomy procedure the user was using a laser probe with the scope and experienced a noisy image. The intended procedure was completed with a different device. There was not pt harm reported.
Patient Sequence No: 1, Text Type: D, B5
[10300116]
The device referenced in this report was returned to olympus for evaluation. The evaluation didn't confirm the user's report of image difficulties, however, there was thermal damage at the distal end and the instruction channel which likely caused or contributed to the reported phenomenon. The device failed the leak test. In addition, there was evidence of fluid invasion inside the bending section. The damage on the scope was likely due to the user 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 | 8010047-2012-00363 |
| MDR Report Key | 2826541 |
| Report Source | 01,05,06 |
| Date Received | 2012-10-19 |
| Date of Report | 2012-09-20 |
| Date of Event | 2012-09-20 |
| Date Mfgr Received | 2012-09-20 |
| Device Manufacturer Date | 2009-03-01 |
| Date Added to Maude | 2012-12-26 |
| 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 | 0 |
| Manufacturer Contact | SUSUMU NISHINA |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal | 192-8507 |
| Manufacturer Phone | 26425177 |
| 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 | 2012-10-19 |
| Model Number | URF-V |
| 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 | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-19 |