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

Model Number LF4418

Device Problem Energy Output Problem (1431)

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

Event Date 08/09/2020

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 a procedure, the surgeon tied of the vessels that did not seal which several of them bled in delayed fashion like 30 seconds after.The surgeon was also convinced that the generator in that room was having issues and asked to have it removed and sent back.The patient had excessive blood loss.The patient's death attributed to the patients metastatic cancer.

• Brand Name: LIGASURE IMPACT
• 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: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 10451514
• MDR Text Key: 204340023
• Report Number: 1717344-2020-00926
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521612525
• UDI-Public: 10884521612525
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/25/2020

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: 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: 08/09/2020
• Initial Date FDA Received: 08/25/2020
• 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