BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM 90-S SERFAS ENERGY SUCTION PROBE

    MDR report key: 1609539 · Received February 8, 2010

    Report

    Report Number
    2648666-2010-00042
    Event Type
    Malfunction
    Date Received
    February 8, 2010
    Date of Event
    July 29, 2008
    Report Date
    August 5, 2008
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS RETURNED FOR INVESTIGATION. PHYSICAL EXAMINATION OF THE RETURNED PROBE DETERMINED THAT ALL COMPONENTS WERE IN PLACE AS PER DESIGN AND MANUFACTURING SPECIFICATIONS. THE UNIT WAS OPENED AT THE PCB BOARD AREA TO INSPECT THE INTERIOR COMPONENTS OF THE PROBE. CORROSION WAS ALSO FOUND ON THE AWG WIRE SOLDERED TO THE PCB BOARD. THE PRESENCE OF THE WATER WAS IDENTIFIED INSIDE THE PROBE HANDLE. WATER INGRESSION WAS REPLICATED BETWEEN THE OUTER LUMEN AND CORE AREA. WATER INGRESSION COULD CAUSE A SHORT CIRCUIT IN THE PROBE. BASED ON THE CONDITION REPORTED AND THE INVESTIGATION PERFORMED, THE MOST PROBABLE ROOT CAUSES ARE: GLUE DISPENSING FIXTURE DOES NOT DISPENSE THE CORRECT AMOUNT OF GLUE. GLUE DISPENSING FIXTURE WAS SET TO THE INCORRECT PRESSURE. THE OPERATION OF THE GLUING FIXTURES IS VERIFIED PERIODICALLY AND ALL FIXTURES ARE UP TO DATE. THEREFORE, THE FIRST CAUSE WAS DISCARDED. THE SECOND CAUSE CAN BE PREVENTED BY THE INSTRUCTIONS PROVIDED IN THE MANUFACTURING PROCEDURE. THIS IS INTENDED TO MINIMIZE OPERATORS ERROR IN THE ASSEMBLY PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PROBE WAS PLUGGED IN LAYING IN THE FIELD, NOT IN THE JOINT, AND ACTIVATED WITHOUT THE PEDAL OR THE BUTTON BEING PRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5MM 90-S SERFAS ENERGY SUCTION PROBE PROBE GEI STRYKER ENDOSCOPY PUERTO RICO 08150AE2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK