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

Model Number	LXMJ44S
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Patient has failed conservative efforts to lose weight.Patient was brought to the operating suite in stable condition, was positioned supine with pneumatic compression sleeves placed to the legs.Patient also received general anesthesia and was intubated.Abdomen was prepped and draped in sterile fashion.Timeout was performed.When it was time to use the ligasure sealer/ divider, the surgeon noted that there was not enough energy to make the device function well (device was "weak", per surgeon.) the med field representative was contacted whether they could increase the strength, but the answer was no.So, the device was changed to a similar one and the procedure was completed without any further incident.No patient harm.Manufacturer response for electrosurgical, cutting coagulation accessories, ligasure xp (per site reporter).Field representative [redacted] was contacted and will retrieve the device as soon as possible.

• Brand Name: LIGASURE XP
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 21641780
• Report Number: 21641780
• Device Sequence Number: 7756059
• Product Code: GEI
• UDI-Device Identifier: 10884521830967
• UDI-Public: (01)10884521830967(17)300107(10)50080271X(20)01
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/07/2025
• Report Date (Section F): 03/07/2025

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: LXMJ44S
• Device Catalogue Number: LXMJ445
• Device Lot Number: 50080271X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/19/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2025
• 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
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 143 KG
• Date Report Sent to FDA: 03/07/2025