BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4MM 30° C-MOUNT STYLE A ARTHROSCOPE

    MDR report key: 3250039 · Received July 26, 2013

    Report

    Report Number
    0002936485-2013-00310
    Event Type
    Malfunction
    Date Received
    July 26, 2013
    Date of Event
    July 2, 2013
    Report Date
    July 2, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    HRX
    PMA / PMN Number
    K093677
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR INVESTIGATION. THE REPORTED FAILURE MODE WAS CONFIRMED. THE SCOPE WAS EVALUATED BY EYE AND WITH EYE LOUPE TO DETERMINE THE SCOPE HAS A PIECE OF DISTAL TIP MISSING. THE DISTAL TIP HAS FIBER AND OUTER TUBE DAMAGE. THE FIBER DAMAGE IS SEVERE ENOUGH TO ALLOW MOISTURE INTO THE SCOPE WHEN STERILIZED. THE ROOT CAUSE WAS TRACED TO BE THAT THE DAMAGES OCCURRED DURING USE/HANDLING BY THE CUSTOMER. IN SUM, THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A MISSING PIECE FROM THE DISTAL TIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A MISSING PIECE FROM THE DISTAL TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351202 4MM 30° C-MOUNT STYLE A ARTHROSCOPE ARTHROSCOPY HRX STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1