BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAMERA HANDLE, W/RIDGE ALUMINUM

    MDR report key: 3122809 · Received May 21, 2013

    Report

    Report Number
    0002031963-2013-00032
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 2013
    Manufacturer
    STRYKER-COMMUNICATIONS
    Product Code
    FSY
    PMA / PMN Number
    K060802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A CAPA WAS INITIATED TO FURTHER INVESTIGATE THE REPORTED EVENT OF THE CRACKED GLASS IN THE STERILIZABLE IN-LIGHT CAMERA COVER. THROUGH INVESTIGATION, THE COVERS WERE FOUND TO MEET DESIGN SPECIFICATIONS. STERILIZATION TESTS WERE ALSO PERFORMED AND IT WAS FOUND THAT THE STERILIZATION PROCESS DID NOT CAUSE THE GLASS TO CRACK. THE ROOT CAUSE WAS DETERMINED TO BE INSUFFICIENT DESIGN AND INSUFFICIENT PROTECTION OF THE GLASS PANE IN THE CAMERA COVER TO WITHSTAND USERS DROPPING THE CAMERA COVERS DURING HANDLING AND INSTALLATION OF THE COVERS. AS A RESULT, A DESIGN CHANGE WAS IMPLEMENTED TO IMPROVE THE QUALITY OF THE COVERS. ALSO THROUGH INVESTIGATION, IT WAS DETERMINED THAT THE RISK INVOLVED WITH THIS EVENT HAS A LIMITED SEVERITY AND A NEGLIGIBLE OCCURRENCE OF HARM ASSOCIATED WITH IT. NO INJURIES HAVE BEEN REPORTED AS A RESULT OF A CRACK IN THE GLASS OF THE IN-LIGHT CAMERA COVER AND IT IS UNLIKELY THAT ANY INJURIES WOULD RESULT IF THIS EVENT WERE TO REOCCUR.

    Additional Manufacturer Narrative · 1

    THE CAMERA COVER INVOLVED IN THIS REPORT HAS NOT YET BEEN RETURNED FOR EVALUATION. ADDITIONAL INVESTIGATION IS ONGOING. THE GLASS OF THE STERILIZABLE IN-LIGHT CAMERA COVER WAS REPORTED TO HAVE SHOWN SIGNS OF CRACKING. SAMPLES OF THESE CRACKED CAMERA COVERS FROM PREVIOUS REPORTS HAVE BEEN RETURNED TO THE MANUFACTURER AND VISUALLY EVALUATED ALTHOUGH THE CAMERA COVERS INVOLVED IN THIS PARTICULAR EVENT HAVE NOT YET BEEN RETURNED. FURTHERMORE, A STRYKER ENGINEER VISITED A CUSTOMER ACCOUNT FOR ADDITIONAL EVALUATION REGARDING THE USE, CLEANING, AND STERILIZING OF THE CAMERA COVERS BUT NO CONCLUSION AS TO THE CAUSE OF THIS REPORTED EVENT CAN BE DETERMINED AT THIS TIME. THE INVESTIGATION IS ONGOING. THERE WAS NO PATIENT INVOLVEMENT AND NO REPORT OF ANY ADVERSE CONSEQUENCES TO THE PATIENT OR CAREGIVER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT THAT THERE WERE CRACKS ON THE OUTER EDGE OF THE GLASS PORTION OF THE STERILIZATION IN-LIGHT CAMERA COVER. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT THAT THERE WERE CRACKS ON THE OUTER EDGE OF THE GLASS PORTION OF THE STERILIZATION IN-LIGHT CAMERA COVER. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224226 CAMERA HANDLE, W/RIDGE ALUMINUM VISUM LED SURGICAL LIGHT FSY STRYKER-COMMUNICATIONS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1