MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. MEGADYNE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 519689

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 11/14/2023

Event Type  malfunction  

Event Description

Dr.Used the bovie and put it down.She reached for something and the bovie burnt her forearm, through her gown.

• Brand Name: MEGADYNE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.; 4545 creek rd.; cincinnati OH 45242
• MDR Report Key: 18443041
• MDR Text Key: 331884377
• Report Number: 18443041
• 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: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 519689
• 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: 11/17/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/04/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female