BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTPORT FORCEPS

    MDR report key: 879461 · Received July 12, 2007

    Report

    Report Number
    2210968-2007-00651
    Event Type
    Malfunction
    Date Received
    July 12, 2007
    Date of Event
    June 1, 2007
    Report Date
    June 12, 2007
    Manufacturer
    ETHICON, INC.
    Product Code
    DWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE RETURN OF THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. IF ANY FURTHER INFORMATION IS RECEIVED OR DERIVED FROM AN EVALUATION, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MITRAL VALVE REPLACEMENT PROCEDURE, THE SURGEON WAS EXPERIENCING DIFFICULTY WITH THE FORCEPS WHEN ATTEMPTING TO GRASP TISSUE. THE FORCEPS WERE SET ASIDE AND ANOTHER DEVICE WAS USED IN THE CASE WITH NO ADVERSE PATIENT CONSEQUENCES. THE FORCEPS THAT WERE NOT WORKING PROPERLY WERE THEN STENT TO BE CLEANED AND STERILIZED. THIS IS DONE VIA SOAKING THE DEVICE IN HAND WASHING IT PRIOR TO IT BEING PLACED IN AN AUTOCLAVE. ONCE THIS WAS COMPLETED, THE NURSE WENT TO INSPECT THE DEVICE AND WHILE DOING SO, ONE OF THE JAWS BROKE OFF IN HER HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTPORT FORCEPS FORCEPS DWS ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR