MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2012-04-05 for OLYMPUS URETERO-RENO VIDEOSCOPE URF-V manufactured by Olympus Medical System Corporation.
[2604573]
Olympus was informed that the device was used during an unidentified procedure in which the device was reportedly broken. There was no further detail provided, and no report of pt harm.
Patient Sequence No: 1, Text Type: D, B5
[9954869]
Olympus followed-up with the user facility via phone and in writing to obtain add'l info, and was informed that the pt was unharmed, but there was no add'l detailed info provided. The device referenced in this report was returned to olympus for eval. The eval found the bending cover was torn and there was damage on the mesh unit at the lower portion of the bending section. There were sharp frayed wires protruding from the bending cover which caused the device to leak. The damaged mesh unit was determined to be due to physical damage. The device was refurbished. 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 | 8010047-2012-00110 |
| MDR Report Key | 2539087 |
| Report Source | 06,07 |
| Date Received | 2012-04-05 |
| Date of Report | 2012-03-07 |
| Date of Event | 2012-03-06 |
| Date Mfgr Received | 2012-03-07 |
| Date Added to Maude | 2012-05-23 |
| 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, TOYKO 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 | 2012-04-05 |
| Returned To Mfg | 2012-03-09 |
| 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, TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-05 |