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

Model Number	LS1037
Medical Device Problem Codes	Energy Output Problem (1431); Difficult to Open or Close (2921); Intermittent Energy Output (4025); Separation Problem (4043)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Tissue Injury (4559)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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, at the beginning of a hysterectomy procedure, the handpiece did not coagulate properly, the handle of the clamp could not be opened and it tore off the coagulated tissue causing bleeding, so it had to be changed.There was no re-grasp alert and activation tone was heard when the connection was made.The clamp was wiped with a wet compress (with saline solution) after the cut seal was performed.Handpiece was able to complete two to three good seals before the issue occurred.The video was submitted showing jaws cannot be opened and uterine tissue was sticking to the jaws.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.A video was also provided.Visual inspection noted that the device sealing tissue.Tissue adhering to the device's seal plate.Functional testing found that without receiving the device, a detail investigation could not be performed for the reported complaint.It was reported that the device was not sealing completely, tissue was sticking and jaws were difficult to open.The reported issues were confirmed.The most likely cause could not be established from the information available.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.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 ATLAS
• 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21079090
• Report Number: 3006451981-2025-00003
• Device Sequence Number: 18239231
• Product Code: GEI
• UDI-Device Identifier: 10884524001630
• UDI-Public: 10884524001630
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K010013
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2025

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: LS1037
• Device Catalogue Number: LS1037
• Device Lot Number: S23A0004
• 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: 12/12/2024
• Supplement Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2023
• 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
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 73 KG