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 2013-07-23 for OLYMPUS URETERO-RENO VIDEOSCOPE URF-V manufactured by Olympus Medical Systems Corporation.
[3624452]
Olympus was informed during a transurethral ureterolithotripsy, users found ureteral injury after second stone retrieval. When the doctor looked at ureteral, retroperitoneum was observed through injured ureteral. As a result of the check by contrast media, users decided stent placement is not enough and performed open abdominal surgery, and the procedure was reportedly completed. The user facility also informed that ureteral injury may occurred while retrieving stones by a basket.
Patient Sequence No: 1, Text Type: D, B5
[10979388]
Olympus followed up with user facility to obtain additional information. The user facility informed that ureteral access sheath may be inserted forcibly while retrieving stones by a basket and that may be attributed to the patient's injury. The subject device was returned to olympus for evaluation. Evaluation revealed there was no abnormality on the device. The cause of the reported phenomenon could not be conclusively determined, however common complication of tul procedure cannot be ruled out as a contributory factor. 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 | 8010047-2013-00231 |
| MDR Report Key | 3262368 |
| Report Source | 01,05,06 |
| Date Received | 2013-07-23 |
| Date of Report | 2013-06-27 |
| Date of Event | 2013-06-27 |
| Date Mfgr Received | 2013-06-27 |
| Device Manufacturer Date | 2013-04-01 |
| Date Added to Maude | 2013-08-05 |
| 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 | HIROKI MORIYAMA |
| Manufacturer Street | 2951 ISHIKAWA-CHO |
| Manufacturer City | HACHIOJI-SHI, TOKYO 192-8507 |
| Manufacturer Country | JA |
| Manufacturer Postal | 192-8507 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS URETERO-RENO VIDEOSCOPE |
| Generic Name | URETERO-RENO VIDEOSCOPE |
| Product Code | GCQ |
| Date Received | 2013-07-23 |
| Returned To Mfg | 2013-07-12 |
| Model Number | URF-V |
| Catalog Number | URF-V |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-07-23 |