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

Lot Number 186598

Device Problems Crack (1135); Material Puncture/Hole (1504)

Patient Problem Burn, Thermal (2530)

Event Date 07/18/2019

Event Type  malfunction  

Event Description

During an operative procedure, the surgeon was using a bovie with a megadyne tip (lot #1866598).It was functioning perfectly then all of the sudden a burn on the pt was noted by the operating room tech and upon further inspection of the megadyne tip, the insulation had a hole with charring around the hole.All megadyne tips with similar lot numbers were pulled and examined.One tip was found to have cracks in the insulation.Fda safety report id# (b)(4).

• Brand Name: MEGADYNE BOVIE TIP
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS INC. ; draper UT 84202
• MDR Report Key: 8822258
• MDR Text Key: 152221039
• Report Number: MW5088326
• Device Sequence Number: 2
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/19/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/30/2023
• Device Lot Number: 186598
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29 YR
• Patient Weight: 95