MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS INC MEGADYNE J HOOK; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Lot Number	201772
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	11/05/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
During right vats procedure the patient was burned in two places, about the size of a quarter and a dime, on the right lateral side due to a malfunction in the j-hook bovie tip that was used.Upon inspection of the j-hook, a hole was noted in the middle of the shaft causing the burns.Fda safety report id # (b)(4).

• Brand Name: MEGADYNE J HOOK
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS INC; draper UT 84020
• MDR Report Key: 10903056
• Report Number: MW5098068
• Device Sequence Number: 3217326
• Product Code: GEI
• UDI-Device Identifier: 10614559100356
• UDI-Public: (01)10614559100356
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/20/2020

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 Expiration Date: 04/30/2025
• Device Lot Number: 201772
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/24/2020
• 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; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 92