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

Model Number	LF5644
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
We had an incident with a l-hook ligasure retractable l-hook laparoscopic sealer divider.Product number is lf5644.It worked fine as a ligasure, but when we deployed the hook, it would not function.The doctor is familiar with this instrumentation.It is new to the staff, but it is not new to her.She's been using it for 15 plus years.It is about 945 when the issue began.We are doing a laparoscopic hysterectomy with bilateral salpingo-oophrectomy, uterus 250 grams or less.It is our first case of the day.There was no patient injury.It was just a slight delay of maybe 10 minutes trying to get another piece of equipment.We went on with a standard laparoscopic l-hook and cord and foot pedal, which most other doctors use and we are proceeding with the procedure.

• Brand Name: LIGASURE
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): COVIDIEN; 60 middletown ave; north haven CT 06473
• MDR Report Key: 25300509
• Report Number: 25300509
• Device Sequence Number: 9306835
• Product Code: GEI
• UDI-Device Identifier: 10884521521742
• UDI-Public: (01)10884521521742(17)290702(10)41850022X(20)01
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/19/2026
• Report Date (Section F): 05/19/2026

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
• Operator of Device: Health Professional
• Device Model Number: LF5644
• Device Catalogue Number: LF5644
• Device Lot Number: 41850022X
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/27/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/27/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 96 KG
• Date Report Sent to FDA: 05/19/2026