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

Model Number LF1212A

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/04/2024

Event Type  malfunction  

Event Description

According to the reporter, during c-section on a dog, the device activation and end tone were heard but sealing was inadequate/partial.The ovarian arteries did not seal and resulted to hemorrhage.Loss approximately 10% of the patient¿s blood volume and recovered.Ligations to stop bleeding where ligasure failed.No blood transfusion was required.Bleeding was observed directly from the ligasure seal, the vessel was fully transected.Another ligasure device was used successfully.

Manufacturer Narrative

D10: concomitant product: forcetriad, forcetriad force triad energy platform (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.The device was available for evaluation.Visual inspection noted that the jaw overmold was cracked.Functional testing noted that the device's jaw opening and closing mechanism was functioning properly.The blade moved smoothly along the knife track and returned to the home position when the trigger was released.The knife cut of the device was tested on a silicone test strip with acceptable results.The jaw gap of the device was measured and it was found to be within specification.The device was plugged in and detected by generators.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.No electrical or wiring issues were found.It was reported that the device activation and end tone were heard but sealing was inadequate/partial.The reported issue was 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.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 c-section on a dog, device activation and end tone heard but sealing inadequate/partial.There was a re-grasp alert.The ovarian arteries did not seal and hemorrhage resulted, loss approximately 10% of the blood volume and recovered.No blood transfusion required.Ligations used to stop the bleeding where ligasure failed.The sealing of the device varied; there would be a few in a row, then a few would not seal appropriately, then would have a few good seals.The pattern was quite variable.Cleaning of the device nearly every time.The amount of tissue grasped was in line with the amount that surgeon have grasped previously when using the device did not run into any issues.Bleeding observed directly from the ligasure seal, vessel fully transected.Another ligasure device used successfully.

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.

• 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: 18588351
• MDR Text Key: 334835282
• Report Number: 1717344-2024-00242
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521744189
• UDI-Public: 10884521744189
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152286
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LF1212A
• Device Catalogue Number: LF1212A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/13/2024
• 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
• Treatment: PLEASE SEE NOTE ON H10.
• Patient Age: 3 YR
• Patient Sex: Female
• Patient Weight: 3 KG