BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.3MM 30° AUTOCLAVABLE ARTHROSCOPE WITH SPEED-LOCK

    MDR report key: 2990435 · Received March 5, 2013

    Report

    Report Number
    0002936485-2013-00050
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 8, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    HRX
    PMA / PMN Number
    K093677
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. THE REPORTED FAILURE MODE COULD NOT BE CONFIRMED. BASED ON PREVIOUS COMPLAINTS, POSSIBLE ROOT CAUSES FOR "BREAKAGE OF RODS IN THE SCOPE" COULD BE: USER MISUSE/MISHANDLING AND/OR IMPROPER PACKAGING. HOWEVER, THIS CANNOT BE CONFIRMED SINCE THE UNIT WAS NOT RETURNED. IN THE EVENT THAT THE UNIT IS RETURNED, A FULL EVALUATION WILL BE CONDUCTED A FOLLOW UP REPORT WILL BE ISSUED. IN SUM, THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE COULD NOT BE CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCOPE DID NOT FUNCTION AS INTENDED DURING A PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCOPE DID NOT FUNCTION AS INTENDED DURING A PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92916 2.3MM 30° AUTOCLAVABLE ARTHROSCOPE WITH SPEED-LOCK ARTHROSCOPE HRX STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1