MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-01 for OLYMPUS WA22607D manufactured by Olympus Winter Ibe Gmbh.
[134727078]
While the doctor was using the button turp loop, the loop broke while cauterizing the prostate. The ends of the loop curled up. Entire loop is still there, just curled up at the ends. New loop obtained and the procedure continued with no harm to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8296547 |
| MDR Report Key | 8296547 |
| Date Received | 2019-02-01 |
| Date of Report | 2019-01-22 |
| Date of Event | 2019-01-09 |
| Report Date | 2019-01-22 |
| Date Reported to FDA | 2019-01-22 |
| Date Reported to Mfgr | 2019-02-01 |
| Date Added to Maude | 2019-02-01 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS |
| Generic Name | ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL |
| Product Code | NLW |
| Date Received | 2019-02-01 |
| Model Number | WA22607D |
| Catalog Number | WA22607D |
| Lot Number | 806847 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS WINTER IBE GMBH |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-01 |