MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-30 for HF-RESECTION ELECTRODE A22203C manufactured by Olympus Medical Systems Corporation.
[185506024]
Patient was under general anesthesia for resection of the prostate and during the procedure the surgical technician realized that the electrode, loop, 28 fr had a broken tip. The two parts given to manager follow up.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9897194 |
| MDR Report Key | 9897194 |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-28 |
| Report Date | 2020-03-24 |
| Date Reported to FDA | 2020-03-24 |
| Date Reported to Mfgr | 2020-03-30 |
| Date Added to Maude | 2020-03-30 |
| 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 | HF-RESECTION ELECTRODE |
| Generic Name | ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL |
| Product Code | FAS |
| Date Received | 2020-03-30 |
| Model Number | A22203C |
| Catalog Number | A22203C |
| Lot Number | 1000042844 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |