BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM AGGRESSIVE PLUS CUTTER, FORMULA (5BX)

    MDR report key: 4241757 · Received November 10, 2014

    Report

    Report Number
    0002936485-2014-00885
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 17, 2014
    Report Date
    October 17, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GFF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 CAUSED BY: FRICTION DUE TO CUTTER ASSEMBLY AND HOUSING ASSEMBLY INTERACTION POOR SUCTION. EXCESSIVE FORCE APPLIED BY THE USER. SHAVER BLADE COMES IN CONTACT WITH A METAL OBJECT (I.E. SCOPE). REUSED SHAVER BLADE. COMPONENTS DO NOT FIT PROPERLY. SHAVER BLADE DEFLECTS EASILY FORCING THE HOUSING ASSEMBLY TO CONTACT THE CUTTER ASSEMBLY. INADEQUATE DESIGN STACKUP. SPRING WITH SPRING CONSTANT TOO HIGH. IMPROPER CLEANING PROCESS. SETTINGS USED ABOVE THE RECOMMENDED LIMITS. INCORRECT RFID TAG. IN SUM, THE REPORTED FAILURE COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RECEIVED FOR INVESTIGATION.

    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: FRICTION DUE TO CUTTER ASSEMBLY AND HOUSING ASSEMBLY INTERACTION; POOR SUCTION; EXCESSIVE FORCE APPLIED BY THE USER; SHAVER BLADE COMES IN CONTACT WITH A METAL OBJECT (I.E. SCOPE); REUSED SHAVER BLADE; COMPONENTS DO NOT FIT PROPERLY; SHAVER BLADE DEFLECTS EASILY FORCING THE HOUSING ASSEMBLY TO CONTACT THE CUTTER ASSEMBLY; INADEQUATE DESIGN STACKUP; SPRING WITH SPRING CONSTANT TOO HIGH; IMPROPER CLEANING PROCESS; SETTINGS USED ABOVE THE RECOMMENDED LIMITS; INCORRECT RFID TAG. 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 THE TIP OF THE UNIT BROKE OFF AND FELL INTO THE PATIENT, BUT WAS RETRIEVED SUCCESSFULLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE UNIT BROKE OFF AND FELL INTO THE PATIENT, BUT WAS RETRIEVED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723306 4.0MM AGGRESSIVE PLUS CUTTER, FORMULA (5BX) BUR, SURGICAL, GENERAL & PLASTIC SURGERY GFF STRYKER ENDOSCOPY-SAN JOSE 14209CE2

    Patients

    Seq Age Sex Outcome Treatment
    1