MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2012-10-26 for OLYMPUS URETERO-RENO VIDEOSCOPE URF-V manufactured by Olympus Medical Systems Corporation.
[18848049]
Olympus was informed that the distal tip was damaged and the wires were exposed.
Patient Sequence No: 1, Text Type: D, B5
[19220660]
Olympus followed-up with the user facility to obtain additional information regarding this report. The user facility reported that during an ureteroscopy with laser lithotripsy procedure, a reusable holimium laser fiber had exploded 3 inches from the distal end when it was activated. The users reportedly heard a loud pop when the laser fiber had exploded. The pt's urethra was said to have been assessed with no trauma noted. The user facility reported that the procedure was completed with a placement of a silicone stent. The user facility reported that the pt was an outpatient and the incident did not result in hospitalization. The attending physician reportedly had been in practice for 6 months. The user facility reported that the probable cause of the incident might be due to a defective laser fiber in combination with the position of the scope which might have been deflected. There was reportedly no image related difficulty experienced during the procedure. The device referenced in this report was returned to olympus for evaluation. The evaluation confirmed the user's report. The bending cover was leaking due to a cut with broken metal mesh protruding. The bending section was found compressed at 7 mm from the bending section glue on the insertion tube side. The instrument channel was inspected with a borescope with no evidence of laser damages observed. The image was found without any issues. The reported phenomenon was attributed to physical damage. 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 | 8010047-2012-00408 |
| MDR Report Key | 2859954 |
| Report Source | 06,07 |
| Date Received | 2012-10-26 |
| Date of Report | 2012-09-28 |
| Date of Event | 2012-06-27 |
| Date Mfgr Received | 2012-09-28 |
| Date Added to Maude | 2012-12-26 |
| 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 | 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 | 2012-10-26 |
| Returned To Mfg | 2012-09-28 |
| 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 SYSTEMS CORPORATION |
| Manufacturer Address | 2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-26 |