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

Model Number LXMJ37L

Device Problems Device Alarm System (1012); Mechanical Problem (1384); Energy Output Problem (1431)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/16/2023

Event Type  malfunction  

Manufacturer Narrative

D10 concomitant product: vlft10gen, vlft10gen ft series energy platformx1 (sn:(b)(6)) 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 hepatic resection, they are effectively sealing (sound and smoke/bubbles seen) with enough tissue between the jaws, but after 2 hours, the device suddenly stopped sealing and sound an alarm of seal incomplete without opening the latch and still pressing the activation button.This happened at least 5 times.Jaws were cleaned as usual.Additionally, the knife get blocked and did not run, surgeon had to open the latch and close again to be able to run the knife.It did not run completely one time and did not run at all in 3 occasions.During sealing and cut of the hepatic capsule, sometimes (3-4) the sealing was not as good as required, and after sealing and cutting a bleeding happened in the sealing site.No incomplete seal alarm was displayed.No blood transfusion was done.Everything worked fine with the sealing during the end of the surgery.Another ligasure device was used successfully with the same generator in the following procedure of the day and it worked perfectly.

Manufacturer Narrative

H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted eschar build-up on seal plates and in knife track.Melted insulation in the knife track was observed.Upon closer look, some knife damage was observed.It is damage consistent with user mistakenly cutting hard/metallic object, like a clip or staple.Functional evaluation found the device's jaw opening and closing mechanism was functioning properly.All seal cycles were completed satisfactorily and end tones were heard indicating completed activation cycles.No electrical or wiring issues were found.It was reported that there was an issue with alarm activation and device had partial seal.The reported issues could not be confirmed.The most likely cause could not be established from the information available.It was also reported that the knife blade did not advance.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue can occur due to improper cleaning.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: keep the instrument jaws cleaned.Build-up of eschar may reduce the seal and/or cutting effectiveness.Do not engage the cutting mechanism over clips, staples, or other metal objects as damage to the cutter may occur.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 & ACCESSORIES
• 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: 18319477
• MDR Text Key: 330554674
• Report Number: 1717344-2023-01525
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521830936
• UDI-Public: 10884521830936
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K223158
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/22/2024

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
• Device Operator: Health Professional
• Device Model Number: LXMJ37L
• Device Catalogue Number: LXMJ37L
• Device Lot Number: 30480107X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 01/05/2024
• Supplement Dates FDA Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2023
• 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
• Treatment: SEE H10
• Patient Sex: Female