BEUDAMED
    FDA Adverse Event Other Summary report: N

    STIMULONG TSUI KIT

    MDR report key: 2574394 · Received April 12, 2012

    Report

    Report Number
    9611612-2012-00004
    Event Type
    Other
    Date Received
    April 12, 2012
    Date of Event
    November 7, 2011
    Report Date
    March 12, 2012
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    CAZ
    PMA / PMN Number
    K062900
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS POINT NO SPECIFIC CORRECTIVE ACTION DUE TO MITIGATIVE PREVENTION OF HAZARDS IS ASSIGNED TO THIS REPORT. A REVIEW OF THE DEVICE HISTORY RECORD AND RELEVANT RAW MATERIAL HISTORY FILES OF THE REPORTED BATCH DID NOT INDICATE RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT. PRIOR TO SHIPMENT / RELEASE THE DEVICE IS TESTED 100%. CONCLUSION: THE PRESENT DAMAGE OF THE CATHETERS CANNOT BE CAUSED BY THE INTENDED USE OF THE PRODUCT. RATHER WE ASSUME, THAT THE CATHETERS HAVE BEEN PULLED AGAINST THE EDGE OF THE CANNULA WHILE REPOSITIONING. THIS ACTION CAUSED THE VISIBLE KERFES. THEREUPON, THE COIL AND THE STIMULATION WIRE HAVE BEEN TRAPPED. THIS IN TURN CAUSED THE COMING OUT OF THE STIMULATION WIRE AND THE COIL WHILE THE WITHDRAWING OF THE STYLET. AS A RESULT OF THE AVAILABLE DATA WE ASSUME, THAT THE REASON FOR THE DAMAGE IS A LOCAL CAUSE. NO FSCA NECESSARY / INDICATED. ANY FURTHER INFO WILL BE SENT TO THE FDA AS SOON AS IT BECOMES AVAILABLE. IF NO INFO BECOMES AVAILABLE PAJUNK CONSIDERS THIS FILE CLOSED.

    Description of Event or Problem · 1

    (B)(4). USER'S NARRATIVE: "DISINTEGRATION OF TWO CATHETERS: FIRST CATHETER: COIL AND STIMULATING WIRE CAME OUT WITH THE STYLET AND CONNECTOR; SECOND CATHETER: STIMULATING WIRE CAME OUT WHEN THE CONNECTOR WAS REMOVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STIMULONG TSUI KIT KIT, ANAESTHESIA CONDUCTION CAZ PAJUNK GMBH MEDIZINTECHNOLOGIE 531156-35U 916

    Patients

    Seq Age Sex Outcome Treatment
    1 Other