BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EURO-MED ROTATING HANDLE

    MDR report key: 7430358 · Received April 13, 2018

    Report

    Report Number
    1216677-2018-00014
    Event Type
    Malfunction
    Date Received
    April 13, 2018
    Date of Event
    February 28, 2018
    Report Date
    May 26, 2019
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HFB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: X-INITIATED MANUFACTURER'S INVESTIGATION: X-INSPECT RETURNED SAMPLES. ANALYSIS AND FINDINGS: THE RETURNED INSTRUMENT WAS VISUALLY INSPECTED AND FOUND TO BE MISSING ONE PIN (BAR) IN THE BASKET COLLECTION AREA. THIS INSTRUMENT IS PURCHASED FROM A SUPPLIER AND PACKAGED AT COOPERSURGICAL. THIS INSTRUMENT WAS SENT TO THE CUSTOMER IN SEPTEMBER 2010. A REVIEW OF TWO YEAR COMPLAINT HISTORY SHOWS NO OTHER COMPLAINTS FOR THIS ISSUE THE SUPPLIER WAS CONTACTED AND STATED THE PINS ARE WELDED IN USING A LASER WELDING MACHINE. THE PRODUCT IS CONTROLLED BY VISUALLY INSPECTION SEVERAL TIMES THROUGHOUT THE PROCESS. IN ADDITION, PRIOR TO SHIPPING TO COOPERSURGICAL, THE SUPPLIER PERFORMS A FINAL INSPECTION. AT COOPERSURGICAL INCOMING INSPECTION, THE INSTRUMENT IS SAMPLED FOR VISUAL NON-CONFORMITIES AND 100% FUNCTIONALLY CHECKED TO SIMULATE TAKING A SAMPLE USING 2 MIL PLASTIC. IN THIS PARTICULAR INSTANCE, IT IS NOT CLEAR IF THIS INSTRUMENT IS FROM THE ORIGINAL COMPLAINT FROM THE CUSTOMER AS THE CUSTOMER PERFORMED DESTRUCTIVE TESTING ON SOME OF THE INSTRUMENTS. AS PART OF THE CUSTOMER'S INVESTIGATION (STERIPRO), IT APPEARS THERE WAS EXCESSIVE PRESSURE EXERTED ON THE INSTRUMENT. THIS IS ATTRIBUTED TO THE USER. CORRECTION AND/OR CORRECTIVE ACTION: NONE AT THIS TIME. WILL CONTINUE TO MONITOR FOR TRENDING. WAS THE COMPLAINT CONFIRMED? YES. REVIEW AND CLOSURE: RECOMMENDED CONTINUOUS IMPROVEMENT PROGRAM (CIP). PREVENTATIVE ACTION ACTIVITY MONITOR AND TREND TO CIP. REF (B)(4).

    Description of Event or Problem · 0

    "WE ARE INVESTIGATING AN INCIDENT WHERE A BAR FROM A EUROMED ROTATING MORGAN TISCHLER PUNCH BIOPSY "; "ONE OF THE BARS DETACHED DURING THE BIOPSY AND HAD TO BE RETRIEVED AS A FOREIGN BODY FROM THE PATIENT." REFERENCE (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL IS CURRENTLY INVESTIGATING THE REPORTED CONDITION. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW UP REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    "WE ARE INVESTIGATING AN INCIDENT WHERE A BAR FROM A EUROMED ROTATING MORGAN TISCHLER PUNCH BIOPSY REF# (B)(4) - ONE OF THE BARS DETACHED DURING THE BIOPSY AND HAD TO BE RETRIEVED AS A FOREIGN BODY FROM THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274147 EURO-MED ROTATING HANDLE EURO-MED ROTATING HANDLE HFB COOPERSURGICAL, INC. 64-649 1052

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R