MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-31 for URETERO-RENO VIDEOSCOPE URF-V3 manufactured by Olympus Medical Systems Corp..
[125784890]
The subject device has not been returned to olympus medical systems corp. (omsc) but was returned to olympus (b)(4). ((b)(4)). (b)(4) evaluated the subject device and confirmed that the angulation of the bending section of the subject device was locked in down direction and did not work. Omsc reviewed the manufacture history of the device and confirmed no irregularity. The exact cause of the reported event could not be conclusively determined at this time. If additional information becomes available, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[125784891]
Olympus medical systems corp. (omsc) was informed that during an unspecified procedure, the motion of the bending section of the subject device was blocked. The further information was not provided from the user facility. There was no report of patient injury associated with the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010047-2018-02093 |
| MDR Report Key | 8022867 |
| Date Received | 2018-10-31 |
| Date of Report | 2019-02-22 |
| Date Mfgr Received | 2019-02-13 |
| Device Manufacturer Date | 2017-12-11 |
| Date Added to Maude | 2018-10-31 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR KAZUTAKA MATSUMOTO |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO-TO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal | 192-8507 |
| Manufacturer Phone | 426425177 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | URETERO-RENO VIDEOSCOPE |
| Generic Name | URETERO-RENO VIDEOSCOPE |
| Product Code | NWB |
| Date Received | 2018-10-31 |
| Model Number | URF-V3 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-31 |