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

Model Number	LS1020
Medical Device Problem Codes	Energy Output Problem (1431); Intermittent Energy Output (4025)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant products: forcetriad - forcetriad force triad energy platform, 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
According to the reporter, during a procedure, the device had no seal (no evidence of energy transfer).Device energy sealing problem.The power supply stopped energizing from the middle of the case.There was no bleeding occurred.Good seals were completed at the beginning of use, it was possible to use it without any problems.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the cord plug was partially cut.Functional testing found the device's jaw opening and closing mechanism was functioning properly.The weld integrity of the device was inspected and was found to be within specification.The knife cut of the device was tested on a silicone test strip with acceptable results.The device's knife blade retracted and advanced properly.The heel gap of the device was measured and it was found to be within specification.The device was activated multiple times on a saline soaked gauze pad with satisfactory results.Damage to the device's cord plug prevented the device from activating to seal.This type of damage is consistent with mishandling of the device.It was reported that the device stopped working.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.It was also reported that the device had no seal.The reported issue could not be 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.The instructions included with this device provide the following guidance: inspect the instrument and cords for breaks, cracks, nicks, or other damage before use.If damaged, do not use.Failure to observe this caution may result in injury or electrical shock to the patient or surgical team or cause damage to the instrument.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: 19625289
• Report Number: 3006451981-2024-00088
• Device Sequence Number: 8485923
• Product Code: GEI
• UDI-Device Identifier: 10884524001623
• UDI-Public: 10884524001623
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2024

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: LS1020
• Device Catalogue Number: LS1020
• Device Lot Number: S2A0101X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2022
• 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