MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-09 for FORCE TRIAD manufactured by Covidien.
[6429942]
Pt in for robotics surgery. During case surgeon had complaints about monopolar not working properly. Connections were checked and bovie pad was resecured after finding that the connection point at the cord was lifted. No alarms on the machine had gone off. Monopolar cord was also replaced. After checking connections, cautery seem to work fine per surgeon. At the end of the case, the grounding pad was removed and an approximately one inch abrasion/burn was noted at the bovie pad edge opposite the connection point. Surgeon assessed site and applied silvadene cream to the site. Bovie and all pads, cords removed from service. Risk management contacted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5044258 |
| MDR Report Key | 4921968 |
| Date Received | 2015-07-09 |
| Date of Report | 2015-07-09 |
| Date of Event | 2015-07-08 |
| Date Added to Maude | 2015-07-20 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FORCE TRIAD |
| Generic Name | FORCE TRIAD |
| Product Code | ODA |
| Date Received | 2015-07-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-09 |