MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-07-25 for BOVIE MEDICAL AA21 manufactured by Bovie Medical Corporation.
[114972706]
Bovie medical received a medwatch report mw5078136 in which a reported complaint that alleged that the tip of a cautery flew and caused a fire with a gauze. The information provided alleged that the fire was extinguished and there were no patient or user injury. Only a type of procedure and the issue was provided to bovie. Based on the information provided, it was determined that the medwatch report matches with a reported complaint for a similar event. Bovie medical completed an evaluation of the reported complaint and determined that the complaint did not meet the reportability criteria. The tips are designed to cut soft tissue. The cautery tip reaches the extreme temperature to achieve the intended use. The extreme temperature will create a reduction in the structural strength of the wire of the tip. At the extreme temperature and corresponding reduction in structural strength, it is possible that the tip will break if excessive pressure is applied. It should be noted that the minute the tip breaks and the tip looses power the temperature will immediately reduce to a temperature that the tips structural strength returns. It is extremely unlikely that the tip will break in more than one location due to the immediate loss in power and temperature. Severity: negligible (no adverse health consequence or clinically insignificant adverse health consequence; or clinically insignificant prolongation or delay of the procedure with no adverse health consequence, temporary discomfort, inconvenience). Occurrence: unlikely - misuse of the product. Bovie medical instructions for use includes warnings and cautions regarding the use of the device in the proximity of flammable agents. The following warnings are included in the ifu: do not use in the presence of flammable gases/materials or in oxygen rich environments. Fire could result. Cautery produces heat in excess of 1000 degrees f, which can cause burns or fire from misuse. Reported complaint was not confirmed, no additional information was provided and the device was not available for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[114972707]
The reported complaint alleged that during a cyst procedure, a tip of the cautery sizzled and flew off. At the same time, the gauze caught on fire. No patient injury resulted from the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007593903-2018-00039 |
| MDR Report Key | 7718415 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-07-25 |
| Date of Report | 2018-07-17 |
| Report Date | 2018-06-28 |
| Date Reported to FDA | 2018-06-28 |
| Date Reported to Mfgr | 2018-07-02 |
| Date Mfgr Received | 2018-04-30 |
| Date Added to Maude | 2018-07-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MRS. DANNELLE LAO |
| Manufacturer Street | 5115 ULMERTON ROAD |
| Manufacturer City | CLEARWATER FL 337604004 |
| Manufacturer Country | US |
| Manufacturer Postal | 337604004 |
| Manufacturer Phone | 7278038554 |
| Manufacturer G1 | BOVIE MEDICAL CORPORATION |
| Manufacturer Street | 5115 ULMERTON ROAD |
| Manufacturer City | CLEARWATER FL 337604004 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 337604004 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BOVIE MEDICAL |
| Generic Name | AA21 |
| Product Code | HQP |
| Date Received | 2018-07-25 |
| Model Number | AA21 |
| Catalog Number | AA21 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOVIE MEDICAL CORPORATION |
| Manufacturer Address | 5115 ULMERTON ROAD CLEARWATER FL 337604004 US 337604004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-25 |