BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORMULA SHAVER HANDPIECE (WITH BUTTONS)

    MDR report key: 4090669 · Received September 15, 2014

    Report

    Report Number
    0002936485-2014-00730
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 27, 2014
    Report Date
    April 10, 2017
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GEI
    PMA / PMN Number
    K071859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ALLEGED FAILURE: SHAVER TURNS OFF ON IT'S OWN. CONFIRMED FAILURE: DAMAGED CABLE (NOT CUT), HI-POT FAILURE. PROBABLE ROOT CAUSE: ISOLATION CIRCUIT FAILURE, MOISTURE GETS INTO HOUSING, DAMAGED MOTOR, DAMAGED/FRAYED CABLE, USE ERROR . THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. (B)(4).

    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: BREAKING RESISTORS ON THE FLEX CIRCUITRY DUE TO STRESS ON FLEX CABLE. MEMBRANE SWITCH BUTTON CONTACT COMES OFF LOCATION DUE TO HEAT FROM STERILIZATION, MOISTURE INGRESS OR STRESS DUE TO IMPROPER ASSEMBLY IMPROPER/INADEQUATE MARKING OF BUTTONS. CONSOLE NOT DELIVERING POWER TO SHAVER. IN SUM, THE REPORTED FAILURE COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RECEIVED FOR INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS UNINTENDED SHAVER ACTIVATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS UNINTENDED SHAVER ACTIVATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS UNINTENDED SHAVER ACTIVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569993 FORMULA SHAVER HANDPIECE (WITH BUTTONS) ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1