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

Model Number	LF1212A
Medical Device Problem Codes	Device Alarm System (1012); Energy Output Problem (1431)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant products: 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
According to the reporter after hemorrhoidectomy procedure, sealing was inadequate/partial (with evidence of energy delivery and end tones heard).Seal cycle errors were also noted.The issue led to severe bleeding to the patient on multiple locations of the body.Suturing was done to stop the bleeding and hospitalization was extended.
Additional Manufacturer Narrative
Correction: b5, h6 (imf and fdp codes were updated).Additional information: 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.
Event or Problem Description
According to the reporter after hemorrhoidectomy procedure, sealing was inadequate/partial (with evidence of energy delivery and end tones heard).Seal cycle errors were also noted.The issue of partial seal led to severe bleeding to the patient on multiple locations of the body after surgery.Suturing was done to stop the bleeding and hospitalization was extended.

• Brand Name: LIGASURE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CH 201114
• Manufacturer (Section G): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CH 201114
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22888895
• Report Number: 3006451981-2025-00089
• Device Sequence Number: 20062425
• Product Code: GEI
• UDI-Device Identifier: 10884521744189
• UDI-Public: (01)10884521744189(17)281212(10)S23MH716
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K152286
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2025

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: LF1212A
• Device Catalogue Number: LF1212A
• Device Lot Number: S23MH716
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 09/17/2025
• Date Device Manufactured: 12/14/2023
• 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: SEE H11
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization
• Patient Sex: Unknown