MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-01-31 for OLYMPUS URETERO-RENO VIDEOSCOPE URF-V UNKNOWN manufactured by Olympus Medical Systems Corporation.
[15861865]
Olympus was informed that "rubber on tip damaged by laser". Olympus followed up with the user facility and was informed that this device had been used in an unspecified urology procedure. There was no pt harm reported.
Patient Sequence No: 1, Text Type: D, B5
[15942964]
Olympus followed up with the user facility to obtain additional information regarding this report. The user facility stated that the reported phenomenon could have likely occurred during an urology procedure and there was no pt injury reported. There was no additional information provided. The device referenced in this report was returned to olympus for evaluation. The evaluation confirmed the user's report. The mesh unit at the lower portion of the bending section was damaged which caused a tear on the bending cover, and a frayed wire was found protruding from the bending cover, causing a leaks. The damage mesh unit was attributed to physical damage due to user handling. This report is being submitted as an mdr in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2012-00023 |
| MDR Report Key | 2455475 |
| Report Source | 06 |
| Date Received | 2012-01-31 |
| Date of Report | 2012-01-05 |
| Date Mfgr Received | 2012-01-05 |
| Date Added to Maude | 2012-04-19 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 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 | 2012-01-31 |
| Returned To Mfg | 2012-01-04 |
| Model Number | URF-V |
| Catalog Number | UNKNOWN |
| 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 | 2012-01-31 |