BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5MM AGGRESSIVE PLUS CUTTER, FORMULA (5BX)

    MDR report key: 3092657 · Received May 3, 2013

    Report

    Report Number
    0002936485-2013-00198
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 9, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GFF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR INVESTIGATION. THE REPORTED FAILURE MODE WAS CONFIRMED. THE UNIT WAS VISUALLY INSPECTED FOR ANY WEAR MARKS OR ASSEMBLY ISSUES THAT COULD BE ASSOCIATED WITH THE REPORTED CONDITION. FURTHER INSPECTION DISCLOSED THAT ONE OF THE CUTTER TEETH (5TH TOOTH ON RIGHT SIDE) HAD BROKEN OFF. AFTER REMOVING THE INNER ASSEMBLY WITH SOME DIFFICULTY, PRONOUNCED WEAR MARKS COULD BE OBSERVED ON THE HOUSING TIP INNER SURFACE AND RADIAL AREA. DENTS WERE OBSERVED ON THE HOUSING WINDOW EDGES, WHICH COINCIDE WITH THE CUTTER TOOTH THAT BROKE OFF. THE INNER CUTTER TIP SEEMED SLIGHTLY BENT, AS A RESULT FROM HITTING THE OUTER HOUSING WINDOW. 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 CAUSE(S) FOR SUBJECT CONDITION 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 (I.E. SCOPE) OR 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 DURING A PROCEDURE, ONE OF THE TEETH OF THE DEVICE CHIPPED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, ONE OF THE TEETH OF THE DEVICE CHIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193651 5.5MM AGGRESSIVE PLUS CUTTER, FORMULA (5BX) BUR, SURGICAL, GENERAL & PLASTIC SURGERY GFF STRYKER ENDOSCOPY-SAN JOSE 13021CE2

    Patients

    Seq Age Sex Outcome Treatment
    1