MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER LIGASURE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number LF1923

Device Problems Device Alarm System (1012); Energy Output Problem (1431); Difficult or Delayed Activation (2577)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/31/2022

Event Type  malfunction  

Event Description

According to the reporter, during a liver resection, sealing with the device became impossible after several times of use, sealing was possible and then could not which became repetitive.A new lf1923 was opened.After that, there were no problem.There was no patient injury.There was no particular setting because it was ligasure.Activation was heard on and off.There was no re-grasp alert.End tone was heard on and off.There was no bleeding.Cleaning of the device was done frequently.About 20-30 times of good seals were completed before the problem occurred.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the unit had a wire failure.Functional testing noted that 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 heel gap of the device was measured and it was found to be within specification.The device produced an instant regrasp alarm when activation attempts were made.The device was disassembled and it was identified that the device's red wire was pinched.It was reported that the ligasure did not seal the vessel.The reported issue could not be confirmed.The most likely cause could not be established from the information available.It was also reported that the device was difficult to activate.The reported issue was confirmed due to the pinched red wire of the device.The cause of failure can be traced to product manufacturing.Internal process improvements have been initiated to mitigate this issue.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: LIGASURE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 15810138
• MDR Text Key: 305493889
• Report Number: 1717344-2022-01417
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521705906
• UDI-Public: 10884521705906
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K170869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2023

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
• Device Operator: Health Professional
• Device Model Number: LF1923
• Device Catalogue Number: LF1923
• Device Lot Number: 21670177X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/02/2022
• Initial Date FDA Received: 11/16/2022
• Supplement Dates Manufacturer Received: 12/28/2022
• Supplement Dates FDA Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1