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)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure, the hand switch was not reacting to the activation and there was mechanical failure of the knife (jaw) when pushing the trigger.Photo observation shows that the wire is cut and sticking out.There was no coagulation.The second ligasure after 2 coagulations the jaws clamped the tissue and would not release, after a few clicks the jaws opened and the instrument stopped working.It failed operation and something inside broke.As a result, the patient started bleeding and they had to stop it.Another ligasure was used successfully with the same generator.
Additional Manufacturer Narrative
D10 concomitant products: ls1037, ls1037 ligasure atlas handswitch37cm (lot#: s23d0012), 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 procedure, the hand switch was not reacting to the activation and there was mechanical failure of the knife (jaw) when pushing the trigger.Photo observation shows that the wire is cut and sticking out.There was no coagulation.The second ligasure after 2 coagulations the jaws clamped the tissue and would not release, after a few clicks the jaws opened and the instrument stopped working.It failed operation and something inside broke.As a result, the patient started bleeding (200 ml) and they had to stop it.To stop the bleeding a clip was placed and the vessel was clamped.Since the patient already had anemia, two doses (500 ml) was administered during the operation as planned.Another ligasure was used successfully with the same generator.
Additional Manufacturer Narrative
Additional information: b5, d1 (brand name), d2 (mfr name and address), d4 (model#, catalog#, exp date, lot#, udi#), g3, g4 (510k), h4 this event has been reassessed and the reportability has been determined to be a reportable serious injury.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 CO 20111 4; CH 201114
• Manufacturer (Section G): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai CO 20111 4; CH 201114
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 23368167
• Report Number: 1717344-2025-01377
• Device Sequence Number: 15677063
• Product Code: GEI
• UDI-Device Identifier: 10884524001630
• UDI-Public: (01)10884524001630(17)280417(10)S23D0012
• Combination Product (Y/N): N
• Initial Reporter Country: KG
• PMA/510(K) Number: K010013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2025

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: S23D0012
• 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: 10/20/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 11/03/2025
• Date Device Manufactured: 04/19/2023
• 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
• Patient Sex: Unknown