MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-14 for SUREFIT 410-2000 manufactured by Conmed Corporation.
[60075193]
A (b)(6) male admitted for an elective neurosurgical procedure on (b)(6) 2016. At the start of the procedure, the neurosurgeon noted the bovie was not delivering the desired power. The procedure was stopped as the circulating rn traced the electrosurgical equipment from pen to generator and noted "green" light present indicating good grounding and can proceed. Then continued tracing to pt at bovie pad. The bovie pad was removed which revealed a small burn at the edge of the pad on the pt's right lateral thigh. The neurosurgeon decided to abort the case due to the burn. A general surgeon assessed the site and excised the burned tissue. This resulted in a 2cm x 6 cm incision wound that was closed with nylon sutures and dressing applied. Sutures to be removed by general surgeon in one week. Original neurosurgical procedure to be rescheduled in 2-3 weeks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6099802 |
| MDR Report Key | 6099802 |
| Date Received | 2016-11-14 |
| Date of Report | 2016-11-10 |
| Date of Event | 2016-11-08 |
| Date Facility Aware | 2016-11-08 |
| Report Date | 2016-11-10 |
| Date Added to Maude | 2016-11-14 |
| 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 | 0 |
| Brand Name | SUREFIT |
| Generic Name | BOVIE PAD |
| Product Code | JOS |
| Date Received | 2016-11-14 |
| Catalog Number | 410-2000 |
| Lot Number | 201506265 |
| Device Expiration Date | 2017-06-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | 525 FRENCH ROAD UTICA NY 135025994 US 135025994 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-14 |