BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND JAW LAP (37CM)

    MDR report key: 4143345 · Received October 6, 2014

    Report

    Report Number
    1717344-2014-00826
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    August 20, 2014
    Report Date
    September 7, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). ONE USED LF1737 WAS RECEIVED FOR EVALUATION AND VISUAL INSPECTION FOUND THE DEVICE WAS DAMAGED DURING SHIPPING. IN ADDITION, THE BLADE HAD BROKEN AWAY FROM THE PULL ROD. THE CUSTOMER REPORTED THAT THE KNIFE HAS BEEN STUCK BETWEEN THE JAWS AND DID NOT RETURN BACK. THE REPORTED CONDITION WAS CONFIRMED. THE BLADE COULD NOT BE RETRACTED OR ADVANCED WITH THE TRIGGER. ENGINEERING DISASSEMBLED THE DEVICE AND FOUND THE WELD ON THE BLADE ROD ASSEMBLY BROKEN. THE INVESTIGATION FOUND NO PIECES MISSING. A DESIGN IMPROVEMENT HAS BEEN IMPLEMENTED. THE DRAWING HAS BEEN CHANGED TO INCREASE THE WELD STRENGTH SPECIFICATION FOR THE BLADE ROD ASSEMBLY. THE INVESTIGATION IDENTIFIED THE ROOT CAUSE OF THE REPORTED EVENT TO BE AN INADEQUATE LASER WELD.

    Description of Event or Problem · 1

    THE CUSTOEMR REPORTED THAT IN THE MIDDLE OF THE SURGERY THE KNIFE BECAME STUCK BETWEEN THE JAWS. UPON RECEIPT FOR INVESTIGATION THE KNIFE BLADE WAS VISUALLY EXPOSED IN THE JAW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623047 MARYLAND JAW LAP (37CM) LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP LF1737 41220141X

    Patients

    Seq Age Sex Outcome Treatment
    1