BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0MM AGGRESSIVE PLUS CUTTER, FORMULA (5BX)

    MDR report key: 2120425 · Received May 27, 2011

    Report

    Report Number
    2648666-2011-00145
    Event Type
    Malfunction
    Date Received
    May 27, 2011
    Date of Event
    April 29, 2011
    Report Date
    May 4, 2011
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED UNIT WAS NOT RETURNED FOR EVALUATION AND THE BROKEN TIP CONDITION COULD NOT BE CONFIRMED. NEVERTHELESS, TIP BREAKAGE IS A KNOWN FAILURE MODE, WHICH PROBABLE ROOT CAUSES, ASSOCIATED RISKS, AND MITIGATION MEASURES ARE CONTEMPLATED WITHIN THE RISK DOCUMENTATION. REVIEW OF THE DEVICE HISTORY RECORD (DHR) OF THE INVOLVED LOT AND PART NUMBER DISCLOSED NO DISCREPANCIES THAT COULD BE ASSOCIATED TO THE REPORTED FAILURE. BASED ON MENTIONED DOCUMENTATION AND EVALUATION OF UNITS RECEIVED FROM PREVIOUS SIMILAR EVENTS, MOST PROBABLE ROOT CAUSES FOR THIS CONDITION CAN BE ASSOCIATED, BUT NOT LIMITED TO: COMPONENTS DO NOT FIT PROPERLY (I.E ALIGNMENT / GAP BETWEEN CUTTER AND HOUSING ASSEMBLY). EXCESSIVE APPLIED PRESSURE. CONTACT OF THE SHAVER BLADE TIP AGAINST A METAL OBJECT. MATERIAL STRENGTH: EVEN THOUGH HISTORICAL DATA HAD SHOWN NO NON-CONFORMANCES ASSOCIATED TO THIS CONDITION, IT IS CURRENTLY BEING EVALUATED BASED ON FRACTURE MODE AND RECURRENCE OF SIMILAR EVENTS. SHOULD THE PRODUCT BE RETURNED, IT WILL BE EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A DELAY IN THE CASE DUE TO A BROKEN PIECE OF THE CUTTER UNIT. IT WAS FURTHER REPORTED THAT IT WAS REMOVED BY THE SURGEON. FURTHER, THE CASE WAS COMPLETED SUCCESSFULLY USING A DIFFERENT UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5.0MM AGGRESSIVE PLUS CUTTER, FORMULA (5BX) CUTTER HRX STRYKER ENDOSCOPY PUERTO RICO 10335CE2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK