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

Catalog Number 0118

Device Problem Thermal Decomposition of Device (1071)

Patient Problem Insufficient Information (4580)

Event Date 06/16/2022

Event Type  malfunction  

Event Description

Narrative from staff: patient came into the operating room to have a tracheostomy.The surgeon asked for a needle bovie tip.The initial setting was 20 for cut and 20 for coag, and it was set to blend.After about 10 to 15 minutes the surgeon asked if the settings could go higher.We then changed the settings to 30/30.After about 10 more minutes there was discussion at the field about how something appeared to be burning.I walked over and found out they were discussing the bovie tip, and the tip of it appeared to be charred.

• Brand Name: MEGAFINE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 4545 creek rd.; cincinnati OH 45242
• MDR Report Key: 14914364
• MDR Text Key: 295233678
• Report Number: 14914364
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/23/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 0118
• Device Lot Number: RKMMBU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/23/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/05/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/05/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23725 DA
• Patient Sex: Male
• Patient Weight: 96 KG