BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 MM RICHARDS 90 DEGREE ANGLE EAR PICK OR HOOK

    MDR report key: 10910 · Received December 17, 1993

    Report

    Report Number
    10910
    Event Type
    Malfunction
    Date Received
    December 17, 1993
    Date of Event
    December 15, 1993
    Report Date
    December 17, 1993
    Manufacturer
    SMITH AND NEPHEW RICHARDS
    Product Code
    JYT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING LEFT STAPEDECTOMY THE ANGLE PORTION OF THE 90 DEGREE ANGLE EAR PICK BROKE OFF IN THE PT'S EAR. THE INSTRUMENT PIECE WAS LEFT IN THE AREA AS THE SURGEON FELT THAT TO TRY TO REMOVE IT WOULD POSE A FURTHER DANGER TO THE PT. THE INSTRUMENT WAS SENT TO ECRI FOR INDEPENDENT ANALYSIS AND THE MFR WAS NOTIFIED OF THE INCIDENT. THE SIZE OF THE EAR PICK WAS 3 MM. THE PT'S DIAGNOSIS WAS BILATERAL OTOSCLEROSIS/HEARING LOSS PRE-OPERATIVELY. THE PT WAS INFORMED OF THE OCCURRENCE BY THE PHYSICIAN AND DISCHARGED ON 12/16/93 WITH FOLLOW-UP TO BE IN THE PHYSICIAN'S OFFICE. (THE PIECE WAS LEFT BECAUSE THE MD FELT TRYING TO REMOVE IT COULD POSSIBLY CAUSE PERMANENT DAMAGE TO THE INNER EAR.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3 MM RICHARDS 90 DEGREE ANGLE EAR PICK OR HOOK EAR PICK OR HOOK JYT SMITH AND NEPHEW RICHARDS 13-0041 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other STAPES PROSTHESIS AND SUTURES.