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

Model Number LF4418

Device Problems Overheating of Device (1437); Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Cardiac Arrest (1762); Bowel Perforation (2668); Embolism/Embolus (4438); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/01/2022

Event Type  Death  

Event Description

According to the reporter, the vessel sealing device was too hot.Information received indicates the patient is deceased.No information was provided regarding the circumstances of expiration or relation to this device.

Manufacturer Narrative

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

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.

Event Description

According to the reporter, 2 days following a vaginal hysterectomy procedure, the patient was complaining of not feeling well.The surgeon believes the jaws of the device used on the original procedure may have gotten too hot and caused the small bowel lacerations.Imaging was performed and it showed that there was fluid present in the abdomen.The patient was brought back to the operating room for an exploratory procedure and lacerations were seen on the small bowel.There were no issues on the day of the original vaginal hysterectomy procedure; however, the surgeon believes that the lacerations may have been caused by the ligasure impact that was used during the original procedure.To try to resolve the issue, the surgeon used sutures to repair the lacerations.After the procedure, the patient was sent to icu to recover.The next day, day 3 postop from original procedure, the patient was brought back to the operating room for an abdominal washout procedure, and the lacerations were seen as still closed.The abdomen was closed and the patient was sent back to icu.The same day, the patient went into cardiac arrest and resuscitation methods were attempted by icu staff, but the patient died.The official cause of the patient's death is still currently unknown as it was stated that postmortem determination can take up to 6 months to complete, but the surgeon believes that the death may have been caused by embolism or a clotting incident.

• Brand Name: LIGASURE IMPACT
• 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 14116673
• MDR Text Key: 289313445
• Report Number: 1717344-2022-00435
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521612525
• UDI-Public: 10884521612525
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K162047
• 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: 05/04/2022

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: LF4418
• Device Catalogue Number: LF4418
• Device Lot Number: LF4418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2022
• Initial Date FDA Received: 04/15/2022
• Supplement Dates Manufacturer Received: 04/08/2022
• Supplement Dates FDA Received: 05/05/2022
• 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): Death; Required Intervention
• Patient Sex: Female