MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-11-29 for CONMED HAND CONTROLLED BOVIE 130307A manufactured by Conmed.
[2964790]
While using the bovie set at 17 and spray during a tonsillectomy and adenoidectomy case after about 20 seconds the bovie tip sparked. The surgeon removed it from the mouth. He stated that he saw a spark. Then a small flame. The bovie tip was replaced using the same handpiece to finish the case and conmed machine. The operating room manager was notified immediately. No injuries were noted by the surgeon. Items used during the procedure included the following: conmed hand controlled bovie (b)(4), lot #120330-3, exp date: 03/2017; conmed needle tip (b)(4), lot #1203301, exp date: 03/2017; covidien 5. 5 mallinckrodt oral cuffed tracheal tube, lot #120301-498x, exp date: 03/2017; conmed system (b)(4). This unit was removed from service and inspected by internal biomedical staff and found no apparent defects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5027925 |
| MDR Report Key | 2858029 |
| Date Received | 2012-11-29 |
| Date of Report | 2012-11-29 |
| Date of Event | 2012-07-06 |
| Date Added to Maude | 2012-12-05 |
| 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 |
| 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 | CONMED HAND CONTROLLED BOVIE |
| Generic Name | BOVIE |
| Product Code | GEI |
| Date Received | 2012-11-29 |
| Model Number | 130307A |
| Lot Number | 120330-3 |
| Device Expiration Date | 2017-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED |
| Brand Name | CONMED NEEDLE TIP |
| Generic Name | NEEDLE TIP |
| Product Code | GEI |
| Date Received | 2012-11-29 |
| Model Number | 138105 |
| Catalog Number | 138105 |
| Lot Number | 1203301 |
| Device Expiration Date | 2017-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | CONMED |
| Brand Name | COVIDIEN 5.5 MALLINCKRODT ORAL CUFFED TRACHEAL TUBE |
| Generic Name | ENDOTRACHEAL TUBE |
| Product Code | LNZ |
| Date Received | 2012-11-29 |
| Lot Number | 120301-498X |
| Device Expiration Date | 2017-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Brand Name | CONMED SYSTEM 50001 |
| Generic Name | SYSTEM |
| Product Code | GEI |
| Date Received | 2012-11-29 |
| Model Number | 50001 |
| ID Number | 014222 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 4 |
| Device Event Key | 0 |
| Manufacturer | CONMED |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-11-29 |