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

Model Number	LS1037
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, during procedure, the device had no seal on mesentery vessel.There was no evidence of energy delivery and end tones was heard.There was no bleeding.Another device was used successfully using the same generator.No medical or surgical interventions needed and event did not lead to or extend patient hospitalization.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 a jaw wire damage.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 blade moved smoothly along the knife track and returned to the home position when the trigger was released.The knife cut of the device was tested on a silicone test strip with acceptable results.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.All seal cycles were completed satisfactorily and end tones were heard indicating completed activation cycles.The device was activated with the rotation knob in various positions to detect any problematic activation issues.The device sealing performance was tested on porcine kidney tissue.Multiple seals on various size vessels were made and a full thermal effect was visually verified.The sealing was adequate when the seal cycle reached end tone.Had this been an assembly defect, the sample would have been rejected if found prior to shipping.It was 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 e valuation detected an unreported condition: of insulation damage.The product analysis noted evidence that the device was not used as intended.This issue may occur if the wire contacted a sharp edge of a trocar device during insertion and/or extraction.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: carefully insert and withdraw instruments from cannulas (trocars) to avoid possible damage to the devices and/or injury to the patient.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: 19774666
• Report Number: 3006451981-2024-00099
• Device Sequence Number: 8654700
• Product Code: GEI
• UDI-Device Identifier: 10884524001630
• UDI-Public: 10884524001630
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2024

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: LS1037
• Device Catalogue Number: LS1037
• Device Lot Number: S23D0005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2023
• 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 Sex: Unknown