MAUDE Adverse Event Report: MICROLINE SURGICAL, INC. RENEW DISPOSABLE SCISSOR TIPS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 3142

Patient Problems Internal Organ Perforation (1987); Superficial (First Degree) Burn (2685)

Event Type  Injury  

Event Description

According to the reporter, during a lap removal of adnexal/ovary, a non-medtronic device was being used with the generator and cord.At the point where the microphone disposable attached to the instrument melted which caused a burn and perforation of the uterus.When instrument was removed everything appeared to be connected properly.The perforation was sutured and additional hospital stay was not required.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: RENEW DISPOSABLE SCISSOR TIPS
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MICROLINE SURGICAL, INC.
• MDR Report Key: 19019097
• MDR Text Key: 339319174
• Report Number: MW5153458
• Device Sequence Number: 1
• 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: Unknown
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 3142
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/01/2024
• Patient Sequence Number: 1