MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. MEGADYNE; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number	0014
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	04/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During the surgical procedure, it was noted that the patient's skin had several burn marks around the incision site.Doctor inspected the bovie tip, which had a break in the insulation.No alarm sound was noted or heard from the valley lab unit.The bovie tip was isolated removed and replaced.The incident was reported to the charge nurse and the bovie tip was handed to her.

• Brand Name: MEGADYNE
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 s. state st.; draper UT 84020
• MDR Report Key: 11759685
• Report Number: 11759685
• Device Sequence Number: 4688896
• Product Code: GEI
• UDI-Device Identifier: 10614559100141
• UDI-Public: (01)10614559100141
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/22/2021
• Report Date (Section F): 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0014
• Device Catalogue Number: 0014
• Device Lot Number: 205224
• Was the Report Sent to FDA?: Yes
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/03/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 72
• Date Report Sent to FDA: 04/26/2021