BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1219930-2014-00496

    MDR report key: 3940766 · Received July 2, 2014

    Report

    Report Number
    1219930-2014-00496
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 30, 2014
    PMA / PMN Number
    K133938
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: WEDGE RESECTION. ACCORDING TO THE REPORTER: THE FIRST FIRING WAS COMPLETED NORMALLY. ARTICULATING THE DEVICE, THE DOCTOR STARTED THE SECOND FIRING. THE SPEED OF FIRING WAS FASTER THAN USUAL AT FIRST AND IT STOPPED IN THE MIDDLE OF FIRING, ABOUT 2CM ALONG THE STAPLE LINE. IT COULD BE RELEASED FROM TISSUE WITH NO DAMAGE INVOLVED. USING ANOTHER SULU WITH NO REINFORCEMENT MATERIAL, THE CASE WAS RECOVERED COMPLETED. ADD'L RESECTION WAS REQUIRED TO CUT THE PART WHERE THE REINFORCEMENT SHEET JAMMED. OPERATING TIME WAS EXTENDED BY LESS THAN 30 MINUTES. THERE WAS NO UNANTICIPATED BLEEDING OF MORE THAN 500CC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other IDRIVE ULTRA POWERED HANDLE 1, IDRVULTRA1,| MANUFACTURE DATE: UNK, EXP DATE: UNK| LOT #: UNK, PMA/510 (K): K121510,