MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-10 for LIGHT-GUIDE CABLE, 2.8 MM, 3 M, CF TYPE WA03300A manufactured by Olympus Winter & Ibe Gmbh.
[174666059]
On december 17, 2019 the manufacturer received medwatch report (mw5091350) that states, "during cystoscopy procedure, room staff noted they smelled something burning and patient moaned in pain so cystoscopy scope was removed. The end of the scope was blackened and scope body also had lighter colored black marks on shaft. This scope was used with an olympus light cable and a karl storz light source. As part of our investigation, multiple follow ups were made to the user facility in an attempt to gather additional information on the reported event; however, no additional information was obtained to date. In addition, the device was not returned to the service center for evaluation. Therefore, the cause of the reported event cannot be determined at this time. This report is for 2 of 2 devices.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2020-00312 |
| MDR Report Key | 9577485 |
| Date Received | 2020-01-10 |
| Date of Report | 2020-01-10 |
| Date of Event | 2019-11-21 |
| Date Facility Aware | 2019-12-16 |
| Date Added to Maude | 2020-01-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIGHT-GUIDE CABLE, 2.8 MM, 3 M, CF TYPE |
| Generic Name | LIGHT GUIDE CABLE |
| Product Code | HBI |
| Date Received | 2020-01-10 |
| Model Number | WA03300A |
| Catalog Number | WA03300A |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS WINTER & IBE GMBH |
| Manufacturer Address | KUEHNSTRASSE 61 HAMBURG 22045 GM 22045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-10 |