BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERT - FENESTRATED 450MM (ID, CEV9625-1)

    MDR report key: 3758874 · Received April 18, 2014

    Report

    Report Number
    9680837-2014-00030
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Report Date
    March 24, 2014
    Manufacturer
    XOMED MICROFRANCE MFG
    Product Code
    GEI
    PMA / PMN Number
    K993655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT DEVICE: CEV9648B5: TUBE CEV9648B5 DIA CEV9648B5 5MM 450MM GREEN, LOT 110701 510K: K993655 MANUFACTURED JULY 2011 (B)(4). PRODUCT EVALUATION: ANALYSIS OF COMPLAINT DEVICE (CEV9625-1) FOUND THAT THE PIN BETWEEN THE WIRE AND THE MOBILE JAW IS BROKEN. THERE ARE FRAGMENTS IN THE PIN HOLES OF THE JAW. NO MATERIAL OR MANUFACTURING DEFECT WAS FOUND. THE MOST PROBABLE CAUSE OF THIS BREAKAGE IS AN EXCESSIVE EFFORT IN TRACTION DURING THE USE OF THE INSTRUMENT. ANALYSIS FOR THE CONCOMITANT DEVICE, CEV9648B5, FOUND NO ISSUE HIGHLIGHTED. INSTRUMENT CONFORMS TO MANUFACTURING SPECIFICATIONS. RESULTS: FRACTURE PROBLEM (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PIN IS MISSING FROM THE INSERT; UNABLE TO OPEN AND CLOSE. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION FROM THE FACILITY STATES THAT THEY BELIEVE ¿THE EVENT OCCURRED WHILE THE INSTRUMENT TECH WAS REASSEMBLING THE DEVICE¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236915 INSERT - FENESTRATED 450MM (ID, CEV9625-1) ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI XOMED MICROFRANCE MFG CEV9625-1 130206

    Patients

    Seq Age Sex Outcome Treatment
    1