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

Model Number LF1923

Device Problem Energy Output Problem (1431)

Patient Problems Death (1802); Blood Loss (2597)

Event Date 03/09/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter during a liver resection, there was an excessive amount of bleeding as the device would not seal properly and there was a weird noise.They were able to still use the device to correct the bleeding.It was not working great but they were able to use it to stop the bleeding.The physician did not get another device; they kept using it to finish the case.It was said it got under control during the case but later the patient had bleeding out in the post anesthesia care unit.The patient has died.

Manufacturer Narrative

Additional information: b1, b5, d10, h1, h3, h6 h3.Evaluation summary: one device was received for evaluation.The returned product met specification as received.Visual inspection found no defects.The reported condition was not confirmed.The device rfid logs were checked and it shows the device has 69 completed seals and 0 regrasp alarms.Functional testing was performed with the returned device on porcine kidney tissue.Multiple seals on various size vessels were made and a full thermal effect was visually verified.The device was activated while pressing the button and with the rotation knob in various positions to detect any problematic activation issues.All seal cycles were completed satisfactorily and end tones were heard indicating completed activation cycles.The device jaw force was also tested and it was found to be within specification.The investigation found the device to function normally and within specifications.The (instructions for use) ifu states, keep the instrument jaws clean.Build up of eschar may reduce sealing and/or cutting effectiveness.Wipe jaw surfaces and edges with a wet gauze pad as needed.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 a liver resection, there was an excessive amount of bleeding as the device would not seal properly and there was a weird noise.They were able to still use the ligasure to correct the bleeding.It was not working great but they were able to use it to stop the bleeding.The physician did not get another device, they kept using it to finish the case.It was said it got under control during the case but later the patient had bleeding out in the post anesthesia care unit.Post blood loss and death of patient was not related to device failure.The patient has died.

• Brand Name: LIGASURE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 9917809
• MDR Text Key: 186198609
• Report Number: 1717344-2020-00395
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521705906
• UDI-Public: 10884521705906
• Combination Product (y/n): N
• PMA/PMN Number: K170869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/24/2020

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: LF1923
• Device Catalogue Number: LF1923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2020
• Initial Date Manufacturer Received: 03/12/2020
• Initial Date FDA Received: 04/02/2020
• Supplement Dates Manufacturer Received: 03/12/2020
• Supplement Dates FDA Received: 04/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death