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

Model Number	LXMJ37L
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	07/01/2025
Type of Reportable Event	Malfunction
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 hysterectomy 5 minutes into the case, the device gave an error tone mid cycle while the surgeon's hand was on the activation button.Then finished the cycle.An alarm with error codes e504 and e502 were noted and there was an energy activation and sealing issue.Specifically inadequate or partial sealing, despite evidence of energy delivery and end tones being heard.The device was being used to seal unknown vessels and tissue of medium thickness and approximately 5-10 good seals had occurred prior to the issue.No cleaning on the jaws was done.Another ligasure device was used successfully with the same generator.No patient complications have been reported as a result of this event.
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 a bend to the shaft of the device.The product analysis found the device's jaw opening and closing mechanism was functioning properly, despite the damage to the shaft.It was reported that the device stopped working, it was not sealing completely and had alarm activation issue.The reported issues could not be confirmed.The most likely cause could not be established from the information available.It was also reported that the device had damaged shaft.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: do not bend instrument shaft.A bent shaft may prevent the instrument from sealing or cutting properly.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: 22641267
• Report Number: 1717344-2025-00964
• Device Sequence Number: 17459679
• Product Code: GEI
• UDI-Device Identifier: 10884521830936
• UDI-Public: 10884521830936
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2025

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: LXMJ37L
• Device Catalogue Number: LXMJ37L
• Device Lot Number: 51210117X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 09/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 48 YR
• Patient Sex: Female