BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM AGGRESSIVE PLUS CUTTER, FORMULA (5BX)

    MDR report key: 3092659 · Received May 3, 2013

    Report

    Report Number
    0002936485-2013-00201
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GFF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION AS IT WAS DISCARDED BY THE CUSTOMER AFTER THE PROCEDURE. HOWEVER, BASED ON THE PICTURES PROVIDED, THE REPORTED FAILURE MODE COULD BE CONSIDERED CONFIRMED. THE DEVICE HISTORY RECORD OF THE REPORTED PRODUCT COULD NOT BE REVIEWED SINCE THE LOT NUMBER WAS NOT AVAILABLE. PROBABLE ROOT CAUSES CAN BE ASSOCIATED, BUT NOT LIMITED TO: (1) COMPONENTS DO NOT FIT PROPERLY (ALIGNMENT/GAP BETWEEN CUTTER AND HOUSING ASSEMBLY) (2) SHAVER BLADE COMES IN CONTACT WITH A METAL OBJECT (E.G. SCOPE) / BONE AND/OR (3) EXCESSIVE FORCE/TORQUE APPLIED BY USER (BENDING/PRYING). IN SUM, THE PRODUCT WAS NOT PHYSICALLY RETURNED FOR INVESTIGATION. HOWEVER, BASED ON THE PICTURES PROVIDED, THE FAILURE MODE COULD BE CONSIDERED CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE TIP OF THE DEVICE BROKE OFF AND WAS RETRIEVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE TIP OF THE DEVICE BROKE OFF AND WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194317 4.0MM AGGRESSIVE PLUS CUTTER, FORMULA (5BX) BUR, SURGICAL, GENERAL & PLASTIC SURGERY GFF STRYKER ENDOSCOPY-SAN JOSE CUSTOMER THREW AWAY THE BOX

    Patients

    Seq Age Sex Outcome Treatment
    1