BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYOVAC SUCTION PUNCH, 2.5 MM / NBH

    MDR report key: 1459034 · Received May 22, 2009

    Report

    Report Number
    1219602-2009-00159
    Event Type
    Malfunction
    Date Received
    May 22, 2009
    Date of Event
    March 23, 2009
    Report Date
    April 29, 2009
    Manufacturer
    MANSFIELD MANUFACTURING SITE
    Product Code
    NBH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS RETURNED FOR EVALUATION. THE DOWEL PIN THAT SECURES THE MOVEABLE JAW TO THE ACTUATOR IS MISSING. THE TOP AND BOTTOM JAW ARE DAMAGED. THE CONDITION OF THE DEVICE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED AND WAS BEING USED FOR SOMETHING OTHER THAN SOFT TISSUE. (B) (4).

    Description of Event or Problem · 1

    DURING SURGERY, IT WAS NOTICED THE SUCTION PUNCH TIP WAS BROKEN. THE ACTUATOR WAS SEPARATED FROM THE TIP OF THE PUNCH, AND THE NORMAL TIP OPENING OF THE PUNCH COULD NOT PERFORM. IT IS UNSURE IF A PIECE WAS LEFT IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYOVAC SUCTION PUNCH, 2.5 MM / NBH NBH MANSFIELD MANUFACTURING SITE 3499 50200947

    Patients

    Seq Age Sex Outcome Treatment
    1