MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-11-20 for ELECTROSURGICAL PENCIL manufactured by Megadyne Medical Products.
[93368703]
A review of the device history record shows this product was originally manufactured to specifications. A review of complaint history was conducted from the last two years and indicated no other reports of this same issue have been reported which indicated a malfunction. Also search of complaint history for reported lot number resulted in no other complaints issued. During initial evaluation, the device was plugged into a esu and continuous electrical connection was observed. The device has been forwarded to megadyne's supplier and investigation is on going to determine cause.
Patient Sequence No: 1, Text Type: N, H10
[93368704]
Bovie pencil was plugged in and automatically turned on. Unplugged and button was not pressed, plugged in again and pencil automatically turned on again. Bovie was replaced with a different bovie with no issues. No patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721194-2017-00009 |
| MDR Report Key | 7045684 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-11-20 |
| Date of Report | 2017-11-27 |
| Date Mfgr Received | 2017-10-24 |
| Device Manufacturer Date | 2017-08-17 |
| Date Added to Maude | 2017-11-20 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS STACEY CASTANEDA |
| Manufacturer Street | 11506 SOUTH STATE STREET |
| Manufacturer City | DRAPER UT 84020 |
| Manufacturer Country | US |
| Manufacturer Postal | 84020 |
| Manufacturer Phone | 8007476110 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELECTROSURGICAL PENCIL |
| Generic Name | ELECTROSURGICAL PENCIL |
| Product Code | JOS |
| Date Received | 2017-11-20 |
| Returned To Mfg | 2017-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEGADYNE MEDICAL PRODUCTS |
| Manufacturer Address | 11506 SOUTH STATE STREET DRAPER UT 84118 US 84118 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-20 |