MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-12 for HF-RESECTION ELECTRODE manufactured by Olympus Winter & Ibe Gmbh.
[130038867]
While in surgery the surgeon reported the hf-resection electrode loop had broken apart. Operating room (or) staff opened another loop and surgery was continued. Metal pieces were flushed into the bladder where surgeon reported that patient would be able to pass microscopic pieces of metal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8154510 |
| MDR Report Key | 8154510 |
| Date Received | 2018-12-12 |
| Date of Report | 2018-12-07 |
| Date of Event | 2018-10-01 |
| Report Date | 2018-12-07 |
| Date Reported to FDA | 2018-12-07 |
| Date Reported to Mfgr | 2018-12-12 |
| Date Added to Maude | 2018-12-12 |
| 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 | 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 | HF-RESECTION ELECTRODE |
| Generic Name | ELECTRODE, ELECTROSURGICAL, ACTIVE |
| Product Code | JOS |
| Date Received | 2018-12-12 |
| Lot Number | 10000024078 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 DA |
| 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 | 2018-12-12 |