BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 3043112 · Received April 9, 2013

    Report

    Report Number
    3005075853-2013-01661
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 11, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTED ADDITIONAL INFORMATION RECEIVED: IN WHAT WAY DID THE DEVICE MISFIRE? IT WAS A PARTIAL FIRING ACCORDING TO THE NURSE IN THE ROOM. ON WHAT TISSUE TYPE WAS THE DEVICE USED? REGULAR BOWEL TISSUE. WHAT LOCATION ON THE TISSUE WAS BEING STAPLED? BOWEL. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC)? FIRST. DURING WHICH FIRING STROKE DID THE EVENT OCCUR? ONE. WHAT COLOR CARTRIDGE WAS BEING USED? UNKNOWN. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? BEFORE UNKNOWN AFTER UNKNOWN. WAS BUTTRESSING MATERIAL USED? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR EXISTING STAPLE LINE(S) OR CLIP(S)? NO. WERE ANY UNEXPECTED NOISES HEARD? NO. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, OPENING OR FIRING)? NO AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS WITHOUT INTERVENTION? UNK. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM TISSUE? NO. DOES THE PATIENT HAVE ANY RELEVANT HISTORY OF SURGICAL TREATMENTS? UNK. HAS THE PATIENT RECENTLY HAD RADIATION OR CHEMOTHERAPY? NO. HOW LONG HAS THE SURGEON BEEN USING THIS DEVICE FOR THIS PROCEDURE (IN YEARS)? ONE OR 2 MONTHS BUT USED OLD NON-POWERED DEVICE FOR A FEW YEARS. WAS THERE A RECENT CONVERSION TO EES DEVICES IN THIS ACCOUNT /SURGEON? NO. THE ANALYSIS FOUND THAT ONE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO CARTRIDGE RELOAD LOADED ON THE DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT POSITION WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. EVENT COULD NOT BE CONFIRMED AS NO CARTRIDGE WAS RECEIVED FOR ANALYSIS. THIS REPORT IS NOT INTENDED TO DENY THAT YOU EXPERIENCED A PROBLEM WITH THE DEVICE. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC BOWEL PROCEDURE THE DEVICE MISFIRED. IT WAS NOTED THAT THE STAPLES WERE PROTRUDING PRIOR TO USE. THE PROCEDURE WAS COMPLETED WITH A SAME/LIKE DEVICE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145639 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4CU8A

    Patients

    Seq Age Sex Outcome Treatment
    1