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

Model Number LF1837

Device Problem Energy Output Problem (1431)

Patient Problems Hemorrhage/Bleeding (1888); Blood Loss (2597)

Event Date 07/15/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during sleeve gastrectomy, the handpiece did not seal at all causing 1.5 liter blood loss and 2 hours extension of surgery time.Generator was used with the handpiece.A competitive device was used to complete the case.

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection observed no notable conditions.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 knife cut of the device was tested on a silicone test strip with acceptable results.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.No electrical or wiring issues were found.The device sealing performance was tested on porcine kidney tissue.The sealing was adequate when the seal cycle reached the end tone.The reported event was not confirmed.The cause could not be determined from the information available.Recently medtronic has identified an increased sensitivity of the jaw to produce re-grasp alarms.Though we have confirmed the blunt tip device conforms to our design and performance specifications, this sensitivity may have contributed to the reported event of no seal and re-grasp alarms.Manufacturing adjustments have been conducted to mitigate this over-sensitivity.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.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 sleeve gastrectomy, multiple (4) failures of cautery, alarms indicating incomplete fusion cycle, patients requiring blood transfusion and intensive care.According to hospital report, company was returning the units saying that they were in working order, with a loss in faith in these devices among staff.The handpiece did not seal at all causing 1.5 liter blood loss and 2 hours extension of surgery time.Ft10 generator was used with the handpiece.A competitive device was used to complete the case.

Manufacturer Narrative

D10 concomitant product/s: vlft10gen vlft10gen ft series energy platformx1 lot/serial #:(b)(6) lf1837 blunt tip sealer divider lf1837 lot/serial #:(b)(6); additional information: b2, b5, d8, d10, e1, e3, e4 (email), g1 (manufacturer name, mfr contact first name, last name, street 1, mfr city, region, postal code, email, phone number), g3, h6 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, CO 55112 ; 7635265677
• MDR Report Key: 10350643
• MDR Text Key: 201355173
• Report Number: 1717344-2020-00816
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521705883
• UDI-Public: 10884521705883
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K162941
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LF1837
• Device Catalogue Number: LF1837
• Device Lot Number: 00520243X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2020
• Initial Date FDA Received: 07/31/2020
• Supplement Dates Manufacturer Received: 10/05/2020; 08/31/2022
• Supplement Dates FDA Received: 10/30/2020; 09/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2020
• 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 Outcome(s): Required Intervention; Other