BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 2940464 · Received December 19, 2012

    Report

    Report Number
    3006451981-2012-00259
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    November 10, 2012
    Report Date
    November 27, 2012
    Manufacturer
    COVIDIEN MEDICAL PRODUCTS SHANGHAI MANUFACTURING. LLC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A HYSTERECTOMY THE KNIFE BLADE WOULD NOT ADVANCE. THE SURGEON OPENED ANOTHER INSTRUMENT TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INJURY. THE DEVICE WAS RETURNED WITH AN INTERNAL PART OF THE SPINDLE CAP MISSING. THE MISSING PART WAS NOT RETURNED. THE CUSTOMER STATED THAT THE PIECE DID NOT FALL INTO THE PATIENT CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN MEDICAL PRODUCTS SHANGHAI MANUFACTURING. LLC S2EF019X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK