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

Model Number LS1020

Device Problem Mechanical Jam (2983)

Patient Problems Tissue Damage (2104); Blood Loss (2597); No Code Available (3191)

Event Date 04/10/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during an emergency laparotomy procedure due to trauma on a motorcycle accident, ten minutes since the start of surgery and upon applying the device on splenic artery, the device's jaws locked on tissue.It was pulled and the splenic artery was torn since the device's jaws never opened.There was blood loss and a blood transfusion was needed.Suture had to be done to resolve the blood loss from the splenic artery.The tissue was 5mm thick and it was not under any tension when the issue occurred.The device was not cleaned.

• Brand Name: LIGASURE ATLAS
• 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: 10057323
• MDR Text Key: 190979873
• Report Number: 1717344-2020-00516
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 20884524001620
• UDI-Public: 20884524001620
• Combination Product (y/n): N
• Reporter Country Code: CS
• PMA/PMN Number: K010013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LS1020
• Device Catalogue Number: LS1020
• Device Lot Number: S9G0015X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2020
• Date Device Manufactured: 07/24/2019
• 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
• Patient Age: 23 YR
• Patient Weight: 65