BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** ETS45 ENDOSCOPIC LINEAR CUTTER

    MDR report key: 3050641 · Received April 10, 2013

    Report

    Report Number
    3005075853-2013-01693
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    February 26, 2013
    Report Date
    March 13, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION RECEIVED: DID THE DEVICE CUT? YES. DID THE DEVICE STAPLE? NO, NOT A FULL STAPLE LINE. ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE? THE FIRST ONE ON THE VENTRICLE, THE LOWER PART. THE SECOND ONE WAS ON THE SMALL INTESTINE. WAS THE DEVICE FIRED ON TISSUE THAT HAD BEEN RADIATED OR HAS THE PATIENT BEEN TAKING SYSTEMIC STEROIDS? NO. WHAT COLOR CARTRIDGE WAS BEING USED? BLUE AND WHITE. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? BLUE. NO CARTRIDGE AFTER SINCE THEY TOOK A NEW INSTRUMENT. WAS BUTTRESSING MATERIAL UTILIZED? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? YES, WHEN CREATING THE GASTRIC POUCH ON A GASTRIC BYPASS, THE SECOND FIRING STARTS WHERE THE FIRSTS STAPLE LINE ENDS. YOU NEED TO CROSS THE STAPLES TO GET A SECURE CLOSURE. WERE ANY UNEXPECTED NOISES HEARD? ON THE FIRST INSTRUMENT, WHEN FIRING, THE HANDLE WHERE VERY HARD TO PRESS. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? YES. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? NO. DEVICE (A) AND (B) WERE RECEIVED IN GOOD VISUAL CONDITION AND WITH A RELOAD IN THE DEVICE. THE RETURNED RELOAD WAS PARTIALLY FIRED WHICH INDICATES THAT THE DEVICE'S FIRING CYCLE WAS INTERRUPTED. WHEN FIRING THE DEVICE MAKE SURE THAT THE FIRING STROKE IS COMPLETED. DO NOT PARTIALLY FIRE THE DEVICE. FIRE THE DEVICE BY SQUEEZING THE FIRING TRIGGER COMPLETELY UNTIL IT RESTS ON THE CLOSING TRIGGER. ONCE THE FIRING CYCLE HAS BEEN INITIATED, IT MUST BE COMPLETED. IF RE-INITIATION OF FIRING IS RESUMED, THE DEVICE WILL LOCKOUT. FIRING THROUGH THE LOCKOUT MECHANISM WILL BREAK THE DEVICE. PLEASE REFERENCE THE INSTRUCTION FOR USE FOR MORE INFORMATION. THE RETURNED DEVICES WERE TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT, AND ALL THE STAPLES FORMED AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE WHEN TRYING TO FIRE THE INSTRUMENT (THE FIRST HANDLE WAS CLOSED) THE SURGEON COULDN'T PUSH THE SECOND HANDLE. THE INSTRUMENT WAS LOADED ACCORDING TO IFU AND WORKED PROPER ON THE FIRST FIRING. THEY HAD ANOTHER INSTRUMENT ON THE SECOND PROCEDURE AND THE SAME THING HAPPENED. THEY TOOK UP ANOTHER INSTRUMENT AND IT WORKED WELL. NO PATIENT CONSEQUENCES REPORTED. PROCEDURE WAS PROLONGED BY TEN MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152052 ENDOPATH** ETS45 ENDOSCOPIC LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK K4C18F

    Patients

    Seq Age Sex Outcome Treatment
    1