BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37CM

    MDR report key: 4181410 · Received October 17, 2014

    Report

    Report Number
    3006451981-2014-00757
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    September 23, 2014
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE USED DEVICE WAS RETURNED AND EVALUATED. VISUAL INSPECTION FOUND THE DEVICE JAWS WERE STUCK SHUT WITH TISSUE. THE JAWS DID NOT OPEN OR CLOSE WHEN THE HANDLE WAS ACTIVATED. THE INVESTIGATION CONFIRMED THE CUSTOMER'S REPORTED CONDITION AND IDENTIFIED THE ROOT CAUSE OF THE REPORTED EVENT TO BE USER ERROR. THE DEVICE HAD BEEN INADEQUATELY CLEANED, WHICH LED TO AN EXCESSIVE BUILDUP OF TISSUE AND ESCHAR IN AND AROUND THE JAWS OF THE DEVICE, EVENTUALLY CAUSING THE JAWS TO NO LONGER OPEN DURING THE PROCEDURE. THE INSTRUCTIONS FOR PROPER CLEANING OF THIS DEVICE ARE INCLUDED IN THE PRODUCT INSTRUCTIONS FOR USE. A DEVICE HISTORY REVIEW WAS COMPLETED AND NO ENTRIES PERTINENT TO THE CUSTOMER'S REPORT WERE NOTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY, THE JAWS OF THE DEVICE WOULD NOT REOPEN WHILE APPLIED TO PATIENT TISSUE. THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION IS AVAILABLE FROM THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660293 LIGASURE ATLAS HANDSWITCHING 37CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) LS1037 S4F0006X

    Patients

    Seq Age Sex Outcome Treatment
    1