BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOUSE STAPES CURETTE, SLIGHT

    MDR report key: 865310 · Received June 14, 2007

    Report

    Report Number
    1423507-2007-00066
    Event Type
    Malfunction
    Date Received
    June 14, 2007
    Date of Event
    May 7, 2007
    Report Date
    June 13, 2007
    Manufacturer
    CARDINAL HEALTH
    Product Code
    JYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US

    Narratives

    Additional Manufacturer Narrative · 1

    BOTH CURETTES WERE RECEIVED FOR INVESTIGATION WITH THE CUPS BROKEN OFF. ITEM #1- LOT CODE "M" - FRACTURE ON SURFACE SHOWS EVIDENCE OF AN EXISTING FRACTURE; APPROXIMATELY 50% OF SURFACE SHOWS DARK COLORED OXIDATION; BALANCE OF SURFACE HAS NO OXIDATION. INDICATION OF A PREVIOUS CRACK IN THE REST OF THE SHAFT FAILED. SURFACE AT FRACTURE INDICATES A FAIRLY BRITTLE TYPE OF FRACTURE INDICATIVE OF A HARDENED MATERIAL OF THIS TYPE. ITEM #2 - LOT CODE "M" - SURFACE OF FRACTURE INDICATES A FAIRLY BRITTLE TYPE OF FRACTURE INDICATIVE OF A HARDENED MATERIAL. REMAINING CUP SHOWS SOME INDICATION OF "HARD" USE - DENTS AND DAMAGE TO THE SHARPENED EDGE. DEVICE HISTORY RECORD WAS REVIEWED AND NO TREND WAS FOUND OR ISSUE NOTED.

    Description of Event or Problem · 1

    THERE WAS PATIENT INVOLVEMENT, BUT NO INJURY. THE CUP ON BOTH OF THEM BROKE OFF DURING SURGERY IN THE SAME SPOT. THEY FOUND ONE CUP, BUT NOT THE OTHER ONE BUT DO NOT BELIEVE IT'S IN THE PATIENT. ADDITIONALLY, ACCOUNT STATED BOTH ITEMS BROKE ON A PATIENT DURING THE SAME MASTOID EAR PROCEDURE. THE PHYSICIAN REMOVED THE BROKEN PIECE FROM THE PATIENT WITH SUCTION WHEN THE FIRST ONE BROKE, BUT WAS NOT ABLE TO LOCATE THE BROKE PIECE ON THE SECOND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOUSE STAPES CURETTE, SLIGHT CURETTE JYG CARDINAL HEALTH AU12450 M

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR