BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALLENGER SWIVEL KNIFE BAYONET BLADE 3MM

    MDR report key: 5885470 · Received August 18, 2016

    Report

    Report Number
    1423507-2016-00063
    Event Type
    Injury
    Date Received
    August 18, 2016
    Date of Event
    July 11, 2016
    Report Date
    September 8, 2016
    Manufacturer
    OERTEL MEDICAL GMBH
    Product Code
    KAS
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS PROVIDED AND AN EVALUATION WAS PERFORMED. THE INSTRUMENT WAS MANUFACTURED IN MARCH OF 2010. THE SWIVEL KNIFE IS SHOWING SIGNS OF WEAR. IT APPEARS AS THOUGH THERE WAS TOO MUCH PRESSURE APPLIED TO THE INSTRUMENT, AND PERHAPS THE USAGE WAS INCORRECT. THE INSTRUMENT NEEDS TO BE INSPECTED BEFORE AND AFTER EACH USE. THERE HAVE BEEN NO ISSUES IDENTIFIED WITH THE MATERIAL OR MANUFACTURING PROCESS. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) DID NOT IDENTIFY AND ISSUES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 1

    (B)(4) ON 12JULY2016, CUSTOMER ADVOCACY SENT THE CUSTOMER AN EMAIL ACKNOWLEDGING RECEIPT OF THE COMPLAINT, PROVIDING THE COMPLAINT NUMBER, AND INQUIRING IF ADDITIONAL INFORMATION MAY BE AVAILABLE. CONFIRMATION WAS ALSO REQUESTED FROM THE CUSTOMER THAT THERE WAS NO PATIENT IMPACT ASSOCIATED WITH REPORTED ISSUE. DEVICE NOT YET EVALUATED, IF THE DEVICE IS EVALUATED A FOLLOW UP WILL BE SENT.

    Description of Event or Problem · 1

    SALES REP REPORTED VIA EMAIL THAT THE BLADE IS BROKEN OFF. ON 10AUG2016 ADDITIONAL INFORMATION: I KNOW IT WAS A SINUS CASE WITH DR. (B)(6). I BELIEVE THEY DID AN X-RAY, AND I KNOW THEY DID NOT FIND IT IN THE PATIENT. THEY COMPLETED THE SURGERY AS PLANNED, AND I NEVER HEARD ANYTHING AFTER INCIDENT, SO I BELIEVE ALL IS WELL WITH PATIENT. IF YOU NEED MORE INFORMATION, PLEASE LET ME KNOW AND I WILL ASK LEAD OR COORDINATOR TO RESPOND ALSO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536992 BALLENGER SWIVEL KNIFE BAYONET BLADE 3MM KNIFE, NASAL KAS OERTEL MEDICAL GMBH RH765-005 XODM03

    Patients

    Seq Age Sex Outcome Treatment
    1 Other