BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0002936485-2014-00379

    MDR report key: 3842518 · Received June 2, 2014

    Report

    Report Number
    0002936485-2014-00379
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 2014
    PMA / PMN Number
    K961971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE WAS NOT RECEIVED FOR INVESTIGATION; THEREFORE, THE REPORTED FAILURE CANNOT BE CONFIRMED. THE COMPLAINT WILL BE CLOSED WITHOUT A DETAILED INVESTIGATION REPORT AND BASED ON PROBABLE ROOT CAUSE. IN THE EVENT THAT THE DEVICE IS RECEIVED, THE COMPLAINT WILL BE REOPENED, A FULL EVALUATION WILL BE CONDUCTED, AND THE INVESTIGATION WILL BE UPDATED WITH THE NEW RESULTS. PROBABLE ROOT CAUSE FOR THE REPORTED FAILURE INVOLVING THIS DEVICE COULD HAVE BEEN PROBABLY CAUSED BY: SAFELIGHT DESIGN; BOOT MATERIAL; LIGHT SOURCE. IN SUM, THE REPORTED FAILURE COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RECEIVED AT STRYKER ENDOSCOPY FOR INVESTIGATION.

    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 LIGHT SOURCE DID NOT GO TO STAND BY AND BURNED THE DRAPE. THE PATIENT WAS NOT BURNED OR HARM. THERE WAS NO DELAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LIGHT SOURCE DID NOT GO TO STAND BY AND BURNED THE DRAPE. THE PATIENT WAS NOT BURNED OR HARM. THERE WAS NO DELAY.

    Patients

    Seq Age Sex Outcome Treatment
    1