BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAPOINT

    MDR report key: 3002663 · Received March 13, 2013

    Report

    Report Number
    2210968-2013-02483
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 12, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    HIH
    PMA / PMN Number
    K994418
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-02482. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOMECTOMY PROCEDURE ON (B)(6) 2013 AND AN ELECTROSURGICAL DEVICE WAS USED. PRIOR TO USING ON THE PATIENT, THE SURGEON NOTED THE TIP OF THE LOOP OF THE WAS BROKEN. ANOTHER LIKE DEVICE WAS USED WITH NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105352 VERSAPOINT ELECTRODE HIH ETHICON, INC. NA UGY1109052

    Patients

    Seq Age Sex Outcome Treatment
    1