MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-02 for DUAL DISPERSIVE ELECTRODE manufactured by Conmed Corporation.
[68849206]
Pt was undergoing anal condyloma ablation with electrocautery. The pt was in the prone position, and dual dispersive electrode pad had been placed on his posterior thigh. The electrocautery generator indicated that the pad was connected effectively (green light). The coagulation was weak, with low suction. Therefore, the team switched to another cautery generator with an air filter smoke evacuator and the cautery continued to be weak. The disposable electrocautery pencil was then changed with no improvement in cautery. The green light was visible on both of the machines. The team then switched to a pressure dressing with surgicel to complete the case. When the drapes were removed, a burn area was noted on the pt's thigh and the electrode where the silver dispersive portion meets the white adhesive area. This was assessed and determined to be a full thickness burn (2cm by 8cm) surrounded by an area of erythema.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068210 |
| MDR Report Key | 6372983 |
| Date Received | 2017-03-02 |
| Date of Report | 2017-03-01 |
| Date of Event | 2017-02-24 |
| Date Added to Maude | 2017-03-02 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | ATTORNEY |
| 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 | DUAL DISPERSIVE ELECTRODE |
| Generic Name | ELECTRODE, ELECTROSURGICAL |
| Product Code | JOS |
| Date Received | 2017-03-02 |
| Lot Number | 201612125 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-03-02 |