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

Model Number LXMJ44S

Device Problems Mechanical Problem (1384); Retraction Problem (1536); Difficult to Open or Close (2921)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/27/2023

Event Type  malfunction  

Event Description

According to the reporter, during a procedure, the device would not cut properly leaving jagged edges.Knife blade could not retract and advance.Patient experienced more bleeding than normal and was taken care of during procedure.Force had to be used to open and close the jaws.Jaws eventually opened after multiple trials.An lf1944 was used successfully with the same generator with version 4.0.4.

Manufacturer Narrative

D10 concomitant product: vlft10gen, vlft10gen ft series energy platformx1 (serial#unknown) 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

Evaluation summary: medtronic conducted an investigation based upon all information received.Two lxmj44s were received for evaluation.Visual inspection noted the jaws were damaged.Pieces of the over-mold appeared to be missing.Functionally, the devices' jaw opening and closing mechanism were functioning properly.The weld integrity of the device was inspected and was found to be within specification.The knife cut of the devices was tested on a silicone test strip with acceptable results.The heel gap of the devices was measured and it was found to be within specification.The devices were recognized by the generator.No electrical or wiring issues were found.It was reported that the jaws were difficult to open, the device was impossible to close, the knife blade did not advance and retract.The reported issues 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: avoid grasping objects, such as staples, clips, or encapsulated sutures in the jaws of the instrument.Use the appropriately sized trocar to allow for easy insertion and extraction of the instrument.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 single anastomosis duodenal-ileal bypass with sleeve gastrectomy, about 0-2 seals of less than 0.2 mm thickness in omentum, the device would not cut properly leaving jagged edges.Patient experienced more bleeding than normal and was taken care of during procedure.No blood transfusion required.Resealed multiple times with ligasure to resolved the bleeding.The device was cleaned about 4-5 times after each every time it came out of the patient.Also, knife blade could not retract and advance.Force had to be used to open and close the jaws.Jaws eventually opened after multiple trials.An lf1944 device was used to seal where the xp had failed, with the same generator with version 4.0.4.

Event Description

According to the reporter, during single anastomosis duodenal-ileal bypass with sleeve gastrectomy, about 0-2 seals, of less than 0.2 mm thickness in omentum, the device would not cut properly leaving jagged edges.Patient experienced more bleeding than normal and was taken care of during procedure.No blood transfusion required.Resealed multiple times with ligasure to resolve the bleeding.The device was cleaned about 4-5 times after every time it came out of the patient.Also, knife blade could not retract and advance.Force had to be used to open and close the jaws.Jaws eventually opened after multiple trials.Opened another lxmj44s device as a remedy for the first device but had the reported issue as the first.An lf1944 device used to seal where the xp had failed, with the same generator with version 4.0.4.

Manufacturer Narrative

Concomitant product: lxmj44s, maryland xp inline sealer/divider 44cm (lot#unknown).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 XP
• 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: 18537066
• MDR Text Key: 333347544
• Report Number: 1717344-2024-00132
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521830967
• UDI-Public: 10884521830967
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K223158
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LXMJ44S
• Device Catalogue Number: LXMJ44S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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