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

Model Number	LXMJ44S
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Per surgeon's notes: patient was brought to the operating room in stable condition having received antibiotics.She was positioned supine and pneumatic compression devices were placed to the legs.She then received general anesthesia, was intubated and an orogastric tube was placed into the stomach.The abdomen was prepped and draped in sterile fashion.Timeout was performed.Gastrocolic ligament now opened on the greater curvature of the stomach with the vessel-sealing device and the lesser sac entered.Ligasure would not seal vessels.Patient continued to bleed with multiple attempts to seal.The device was changed to another similar device and the procedure was completed without further incident.No patient harm.Manufacturer response for electrosurgical, cutting coagulation accessories, ligasure xp (per site reporter).Field med representative has been informed and will retrieve the device in the near future per operating room supervisor.

• Brand Name: LIGASURE XP
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): COVIDIEN; 60 middletown ave; north haven CT 06473
• MDR Report Key: 21251258
• Report Number: 21251258
• Device Sequence Number: 18436466
• Product Code: GEI
• UDI-Device Identifier: 10884521830967
• UDI-Public: (01)10884521830967(17)291016(10)42910015X
• 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): 01/08/2025
• Report Date (Section F): 01/08/2025

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 Lot Number: 42910015X
• 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: 01/28/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/28/2025
• 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: 33 YR
• Patient Sex: Female
• Patient Weight: 107 KG
• Date Report Sent to FDA: 01/08/2025