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

Model Number	LF5637
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a total laparoscopic hysterectomy, the device had inadequate or partial sealing, with evidence of energy delivery and end tones heard.Patient had excessive and severe blood loss after cutting occurred from the vaginal vessels during the takedown of vaginal vessels and cutting of the vaginal cuff.The jaws of the device were cleaned twice during the procedure.No imaging was performed.The procedure was extended by 10-20 minutes due to the need for additional interventions, including placement of additional sutures, re-cauterization, and re-scrubbing during the procedure.The tissue being sealed was approximately 5mm thick and involved uterine vessels; smaller vessels were sealed successfully, but issues arose with larger vessels.
Additional Manufacturer Narrative
D10 concomitant product: vlft10gen, vlft10gen ft series energy platformx1 (serial #: (b)(6)).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during a total laparoscopic hysterectomy, the device had inadequate or partial, as there was no regrasp but with evidence of energy delivery and end tones heard.Patient had excessive and severe blood loss after cutting occurred from the vaginal vessels during the takedown of vaginal vessels and cutting of the vaginal cuff.The jaws of the device were cleaned twice during the procedure.No imaging was performed.The procedure was extended by 10-20 minutes due to the need for additional interventions, including placement of additional sutures, re-cauterization, and re-scrubbing during the procedure.The tissue being sealed was approximately 5mm thick and involved uterine vessels, smaller vessels were sealed successfully but issues arose with larger vessels.No blood transfusion was necessary or done to patient due bleeding.
Additional Manufacturer Narrative
Additional information: b5, g3 medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: LIGASURE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN; 6044 longbow court; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN; 6044 longbow court; boulder CO 80301 3299
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 24604631
• Report Number: 1717344-2026-00372
• Device Sequence Number: 13355262
• Product Code: GEI
• UDI-Device Identifier: 10884521521735
• UDI-Public: (01)10884521521735(17)300923(10)52670321X(20)01
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K161804
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: LF5637
• Device Catalogue Number: LF5637
• Device Lot Number: 52670321X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 03/26/2026
• Date Device Manufactured: 09/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE NOTE ON H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female