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 2012-06-07 for OLYMPUS URETERO-RENO VIDEOSCOPE URF-V manufactured by Olympus Medical Systems Corporation.
[20093698]
The user facility reported that the user experienced difficulty removing the ureteroscope out of the pt's urethra during a procedure. The user attempted pulling out the ureteroscope together with an access sheath from the pt, but unsuccessfully. The ureteroscope was successfully removed from the pt by surgical intervention.
Patient Sequence No: 1, Text Type: D, B5
[20273519]
Olympus followed up with the user facility to obtain add'l info regarding this report, and was informed that a transurethral uretero-lithotripsy (tul) procedure was performed in the pt. There were many calculuses in the pt's urethra reportedly. The user facility reported that the ureteroscope likely got stuck between some calculuses and the pt's ureter wall, and consequently difficulty removing. Olympus was informed in (b)(6) 2012 that the pt was doing fine. The device referenced in this report was returned to olympus for eval. The eval revealed that the bending section cover was scratched on likely with calculuses. 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 | 8010047-2012-00151 |
| MDR Report Key | 2626035 |
| Report Source | 01,05,06 |
| Date Received | 2012-06-07 |
| Date of Report | 2012-05-11 |
| Date of Event | 2012-04-20 |
| Date Mfgr Received | 2012-05-11 |
| Device Manufacturer Date | 2010-12-01 |
| Date Added to Maude | 2012-09-26 |
| 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 | URETERO-RENO VIDEOSCOPE |
| Product Code | GCQ |
| Date Received | 2012-06-07 |
| Returned To Mfg | 2012-05-21 |
| 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, TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2012-06-07 |