BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_ENDOSCOPY_PRODUCT

    MDR report key: 4974155 · Received August 5, 2015

    Report

    Report Number
    0002936485-2015-00708
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    July 9, 2015
    Report Date
    July 9, 2015
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    BZN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    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 CAUSED BY: TOO MUCH HEAT. TRANSFORMER DESIGN. CART DESIGN. MANUFACTURING NONCONFORMITY (TEKNA). USE ERROR. THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE POWER CABLE FROM THE STRYKER TOWER SPARKED DURING THE CASE. SPARKING OCCURRED AT THE PLUG OUTLET AFTER TURNING THE LASER AND TOWER ON. THE ELECTRICIAN AND FACILITY ADMINISTRATOR BOTH ACKNOWLEDGE THAT THE STRYKER TOWER WAS NOT AT FAULT FOR THE ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE POWER CABLE FROM THE STRYKER TOWER SPARKED DURING THE CASE. SPARKING OCCURRED AT THE PLUG OUTLET AFTER TURNING THE LASER AND TOWER ON. THE ELECTRICIAN AND FACILITY ADMINISTRATOR BOTH ACKNOWLEDGE THAT THE STRYKER TOWER WAS NOT AT FAULT FOR THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517799 UNKNOWN_ENDOSCOPY_PRODUCT CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT) BZN STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1