BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE

    MDR report key: 6454144 · Received April 3, 2017

    Report

    Report Number
    3006451981-2017-05115
    Event Type
    Malfunction
    Date Received
    April 3, 2017
    Report Date
    March 8, 2017
    Manufacturer
    COVIDIEN MEDICAL PRODUCTS
    Product Code
    GEI
    PMA / PMN Number
    K043273
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF INITIAL REPORT: (B)(6) 2017, DATE OF FOLLOW-UP REPORT: 2017-06-30. SECTIONS UPDATED WITH NEW INFORMATION. ONE USED LS1500 LIGASURE DEVICE WAS RECEIVED FOR EVALUATION. EXAMINATION OF THE DEVICE FOUND A .3 SQ. MM AREA OF DAMAGED INSULATION ON THE TUBE. THE TYPE OF DAMAGE SEEN IS CONSISTENT WITH SCRAPING THE TUBE DURING INSERTION OR REMOVAL THROUGH A TROCAR. THE INVESTIGATION IDENTIFIED THE ROOT CAUSE OF THE REPORTED EVENT TO BE USER DAMAGE. NO TREND IS ASSOCIATED WITH THIS ISSUE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PURPLE ACTIVATION BUTTON FELL OFF WHEN OPENING THE PACKAGING. THERE WAS AN ATTEMPT TO USE THE DEVICE WITH THE DETACHED PIECE, BUT A REGRASP ALARM WOULD OCCUR. EXAMINATION OF THE RECEIVED DEVICE FOUND THE BLACK TUBE INSULATION IS DAMAGED, EXPOSING THE METAL. A PIECE OF THE INSULATION IS MISSING. THE CUSTOMER CONFIRMED THE PIECE FELL WITHIN THE PATIENT BUT WAS RETRIEVED. THERE WAS NO HARM TO THE PATIENT. EXAMINATION OF THE RECEIVED DEVICE ON MARCH 8 FOUND THE BLACK TUBE INSULATION IS DAMAGED, EXPOSING THE METAL. A PIECE OF INSULATION IS MISSING. THE CUSTOMER CONFIRMED THE PIECE FELL WITHIN THE PATIENT BUT WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235091 LIGASURE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MEDICAL PRODUCTS LS1500 S6HB013X

    Patients

    Seq Age Sex Outcome Treatment
    1