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

Model Number	LXMJ44S
Medical Device Problem Codes	Device Alarm System (1012); Energy Output Problem (1431); Intermittent Energy Output (4025)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: b5, g3, h6 (fdr-c07) 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 laparoscopic sleeve gastrectomy, the device was used to seal lymphatic tissue vessels less than 7mm in thickness.After approximately two to three successful seals, minimal bleeding occurred following completion of sealing and dissection.The device had inadequate or partial, with the generator displaying an "incomplete seal / regrasp tissue" alert, evidence of energy delivery and end tones were noted.The jaws were cleaned as frequently as eschar was observed.Another ligasure device was subsequently used with the same generator and functioned without issue.There was no patient injury and no blood transfusion was needed.
Additional Manufacturer Narrative
D10 concomitant products: vlft10gen, vlft10gen ft series energy platformx1 (serial#:unknown) 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 laparoscopic sleeve gastrectomy, the device was used to seal lymphatic tissue vessels less than 7mm in thickness.After approximately two to three successful seals, minimal bleeding occurred following completion of sealing and dissection.The device had inadequate or partial, with the generator displaying an "incomplete seal / regrasp tissue" alert, evidence of energy delivery and end tones were noted.The jaws were cleaned as frequently as eschar was observed.Another ligasure device was subsequently used with the same generator and functioned without issue.There was no patient injury.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the tip of the seal plate on jaw a was lifted or damaged.Functional testing found that the device's jaw opening and closing mechanism was functioning properly.It was reported that there was alarm activation issue, device stopped working and the device had inadequate or partial seal.The reported issues could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition: of seal plate damage.The product analysis noted evidence that the device was not used as intended.This issue may occur due to a drop, due to the device coming in contact with a hard object or during the insertion or extraction of the device's jaw from a trocar instrument.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.The instructions included with this device provide the following guidance: carefully insert and withdraw the instrument through the cannula to avoid damage to the device or injury to the patient or both.Close jaws using device lever before insertion or extraction in the cannula.Do not attempt to seal or cut over clips or staples as incomplete seals/damage to the cutting blade will occur.Contact between an active electrode and any metal objects may result in alternate site burns or incomplete seals.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 XP
• 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: 24064160
• Report Number: 1717344-2026-00074
• Device Sequence Number: 9350880
• Product Code: GEI
• UDI-Device Identifier: 10884521830967
• UDI-Public: (01)10884521830967(17)291029(10)43040194X
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K223158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/27/2026

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: LXMJ44S
• Device Catalogue Number: LXMJ44S
• Device Lot Number: 43040194X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: 01/07/2026; 03/26/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 01/22/2026; 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2024
• 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.
• Patient Sex: Unknown