MAUDE Adverse Event Report: COVIDIEN LIGASURE; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number LF1937

Device Problem Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Date 05/10/2023

Event Type  malfunction  

Event Description

The trigger is not working.

• Brand Name: LIGASURE
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): COVIDIEN; 60 middletown ave; north haven CT 06473
• MDR Report Key: 16983487
• MDR Text Key: 315756146
• Report Number: 16983487
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521705913
• UDI-Public: 10884521705913
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/12/2023

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 Model Number: LF1937
• Device Lot Number: 22730035X
• 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: 05/12/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/23/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/23/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25550 DA
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Race: White