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

Model Number LF1937

Device Problems Difficult to Open or Close (2921); Separation Problem (4043)

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

Event Date 10/04/2022

Event Type  malfunction  

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.

Event Description

According to the reporter, during procedure, the jaws were difficult to open, there was sticking of the jaw and tissue.Jaws were partially opened.The device did not improve event after being cleaned.It was removed from the tissue by jaw opening and closing, as usual.The jaws were cleaned every each use.Tissue was not under any tension.The knife blade was not extended nor protruded beyond the edge of the jaws.A new device was used to complete the procedure.There was no blood loss and there was no patient injury.

Manufacturer Narrative

H3: evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted minor damage to the device's knife track.Functionally, the damage to the knife blade slot on one of the jaws was identified under high magnification inspection of the seal plate.The damage did not appear to stem from a staple or clamping on a metal object as it was only noticed on one side of the jaw and within the blade slot not top surface of the seal plate.It appears the damage came from the knife itself and the most probable root cause of this complaint can be attributed to when preparing to seal while the knife was partially extended.This can obstruct the closure of the jaws and cause minor damage to the knife track.Manufacturing does 100% inspection during the assembly and packaging processes.The defective sample would have been rejected if found prior to shipping, if this was an assembly defect.The product analysis 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.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.Functional testing was performed on porcine kidney tissue.Multiple seals on various size vessels were made with visually acceptable results.All seal cycles were completed satisfactory and end tones were heard indicating completed activation cycles.No electrical or wiring issues were found.It was reported that the jaws of the device were difficult to open and the jaws of the device were stuck to the tissue.The reported issues could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition: the unit had a seal plate failure.The product analysis noted evidence that the de vice was not used as intended.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: eliminate tension on the tissue when sealing and cutting to ensure proper function.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: 15640591
• MDR Text Key: 305261797
• Report Number: 1717344-2022-01301
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521705913
• UDI-Public: 10884521705913
• 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: 11/04/2022

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: LF1937
• Device Catalogue Number: LF1937
• Device Lot Number: 21460170X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/05/2022
• Initial Date FDA Received: 10/20/2022
• Supplement Dates Manufacturer Received: 10/24/2022
• Supplement Dates FDA Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2022
• 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
• Patient Sex: Female