BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULA, COHEN, W/TWO ACORNS

    MDR report key: 3112006 · Received May 1, 2013

    Report

    Report Number
    1418479-2013-00013
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    November 28, 2012
    Report Date
    April 1, 2013
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Product Code
    HHI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FULL INVESTIGATION COULD NOT BE COMPLETED AS THE ACTUAL DEVICE WAS NOT RETURNED TO THE RICHARD WOLF FACILITY AS OF 04/30/2013. DEVICE IS SCREWED ON TO END OF INTRAUTERINE PROBE. IFU INSTRUCT USER "IMMEDIATELY BEFORE AND AFTER EACH USE, CHECK THE PRODUCTS FOR DAMAGE, LOOSE PARTS AND COMPLETENESS." MOST LIKELY CAUSE OF ACORN COMING LOOSE IS USER ERROR/HANDLING. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. IE INTENDED USE, INDICATIONS AND FIELD OF USE, PREPARATION AND CAUTIONS. TRENDING SHOWED THERE HAS BEEN ONE SIMILAR INCIDENT IN THE LAST FOUR YEARS. (MDR1418479-2011-0020). LOT NUMBER SUPPLIED BY CUSTOMER WAS NOT FOUND IN OUR SYSTEM AND CALLS TO INITIAL REPORTER HAVE NOT BEEN RETURNED. THE LAST PURCHASE OF THIS DEVICE TYPE, FROM THIS CUSTOMER, WAS IN 2008 (LOT 183J08). RWMIC CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT WE RECEIVE THE DEVICE OR ADDITIONAL INFORMATION ISA RECEIVED, WE WILL PROVIDE FDA WITH FOLLOW-UP INFORMATION.

    Description of Event or Problem · 1

    STERILE PROCESSING DEPARTMENT REPORTED ACORN TIP MISSING TWO HOURS POST PROCEDURE. DOCTOR NOTIFIED OF MISSING DEVICE AND SEARCH OF EQUIPMENT, LINENS AND ROOM CONDUCTED WITH NO RESULTS. DOCTOR NOTIFIED PATIENT AND SUGGESTED PATIENT PERFORM SELF EXAMINATION, NOTHING ABNORMAL FOUND. PATIENT PRESENTED TO DOCTORS OFFICE ONE DAY POST-OP WITH PAIN. ACORN WAS FOUND IN VAGINA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191090 CANNULA, COHEN, W/TWO ACORNS CANNULA, COHEN, W/TWO ACORNS HHI RICHARD WOLF MEDICAL INSTRUMENTS CORP. 8378.00

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other