BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM AGGRESSIVE PLUS CUTTER, FORMULA (5BX)

    MDR report key: 3222318 · Received July 12, 2013

    Report

    Report Number
    0002936485-2013-00291
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    May 23, 2013
    Report Date
    June 5, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GFF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF THE UNIT, A TIP BREAKAGE CONDITION WAS OBSERVED. ADDITIONAL INFORMATION WILL BE PROVIDED ONCE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    UPON VISUAL INSPECTION OF THE RETURNED UNIT, THE BROKEN TIP CONDITION ON THE CUTTER WAS CONFIRMED. THE BROKEN PIECE PRESENTED CONSIDERABLE DAMAGE AND DEFORMATION OF THE TEETH. PRONOUNCED FRICTION WEAR MARKS COULD BE OBSERVED ON THE HOUSING WINDOW INNER SURFACE, AS WELL AS SIGNIFICANT DENTS AND DEFORMATION ON THE WINDOW EDGES. REVIEW OF THE DEVICE HISTORY RECORD OF THE SUBJECT PART AND LOT NUMBER DISCLOSED NO MANUFACTURING ISSUES THAT COULD BE RELATED TO THE REPORTED FAILURE CONDITION. PROBABLE ROOT CAUSES CAN BE ASSOCIATED, BUT NOT LIMITED TO: COMPONENTS DO NOT FIT PROPERLY (ALIGNMENT/GAP BETWEEN CUTTER AND HOUSING ASSEMBLY), SHAVER BLADE COMES IN CONTACT WITH A METAL OBJECT (E.G. SCOPE) / BONE AND/OR EXCESSIVE FORCE/TORQUE APPLIED BY USER (BENDING/PRYING). IN SUM, THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SHAVER BROKE OFF IN THE PATIENT AND WAS RETRIEVED. FURTHER, A ONE MINUTE DELAY WAS REPORTED. NO ADVERSE CONSEQUENCES TO THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SHAVER BROKE OFF IN THE PATIENT AND WAS RETRIEVED. FURTHER, A ONE MINUTE DELAY WAS REPORTED. NO ADVERSE CONSEQUENCES TO THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321729 4.0MM AGGRESSIVE PLUS CUTTER, FORMULA (5BX) BUR, SURGICAL, GENERAL & PLASTIC SURGERY GFF STRYKER ENDOSCOPY-SAN JOSE 13099CE2

    Patients

    Seq Age Sex Outcome Treatment
    1