MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-05-06 for OLYMPUS URETERO-RENO VIDEOSCOPE URF-V manufactured by Olympus Medical System Corporation.
[3450509]
Olympus was informed that the image blacked out during an unspecified procedure. There was no patient harm reported.
Patient Sequence No: 1, Text Type: D, B5
[10844016]
Olympus followed-up with the user facility to obtain additional information regarding this report. The user facility reported that the reported phenomenon occurred during a therapeutic ureteroscopy and laser lithotripsy procedure where the image went black almost immediately. The procedure where the image went black almost immediately. The procedure was said to have been aborted as a result of the image loss in addition to no backup endoscope was readily available. There was no patient harm reported. The device referenced in this report was returned to olympus for evaluation. The evaluation confirmed the user's report. There was no image noted and heavy fluid invasion was found inside the control body and in the light-guide connector which likely caused or contributed to the reported image difficulty. However, the device was noted to pass leakage testing. As the device passed leak testing the likely source of the fluid invasion appears to be due to mishandling, likely during reprocessing. The charge-coupled device (ccd) was damaged due to fluid invasion. Additionally, the distal end cover was melted due to mishandling.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010047-2013-00144 |
| MDR Report Key | 3125016 |
| Report Source | 06 |
| Date Received | 2013-05-06 |
| Date of Report | 2013-04-08 |
| Date of Event | 2013-04-05 |
| Date Mfgr Received | 2013-04-08 |
| Date Added to Maude | 2013-07-11 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LAURA STORMS |
| Manufacturer Street | 2400 RINGWOOD AVE |
| 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, 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 | 2013-05-06 |
| Returned To Mfg | 2013-04-18 |
| 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 | 2013-05-06 |