BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 LONG ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60 MM

    MDR report key: 1863538 · Received October 11, 2010

    Report

    Report Number
    3005075853-2010-05788
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 16, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). JAMMED KNIFE THE ANALYSIS FOUND THAT THE (B)(4) DEVICE WAS RECEIVED WITH AN XCEL TROCAR ON THE DEVICE, THE KNIFE JAMMED AND WITH A GREEN CARTRIDGE RELOAD PRESENT. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE DEVICE WAS DISASSEMBLED TO VERIFY THE INTERNAL COMPONENTS THE CLOSURE TRIGGER TOP WAS FOUND DAMAGED. ONE POSSIBLE SCENARIO FOR THE DESCRIBED EVENT IS DUE TO APPLYING A LARGE PRYING FORCE ON THE CLOSURE TRIGGER HANDLE IN THE OPENING DIRECTION. AFTER FURTHER ANALYSIS OF THE TUBE THE KNIFE WAS NOTED TO BE JAMMED. IN ADDITION, SEVERAL B-FORM STAPLES WERE NOTED LODGED BETWEEN THE KNIFE AND THE ANVIL CHANNEL, RESULTING IN THE FIRING MECHANISMS JAMMING. TO MITIGATE THE POTENTIAL FOR STAPLES GETTING INTO THE CARTRIDGE AND INTERFERING WITH THE KNIFE PATH DURING DEVICE FIRING, PRIOR TO RELOADING THE DEVICE, RINSE THE ANVIL AND CARTRIDGE JAW IN STERILE SOLUTION AND THEN WIPE THE ANVIL AND CARTRIDGE JAW TO CLEAN ANY FORMED BUT UNUSED STAPLES FROM THE DEVICE. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4). A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE WHEN THE SURGEON FIRE THE SEVENTH FIRING ACROSS THE FUNDUS ON THE FINAL FIRING IN THE GASTRIC SLEEVE AFTER THREE STROKES THE KNIFE BLADE WOULD NOT RETURN. THE SURGEON COULD NOT REMOVE THE DEVICE FROM THE TISSUE; THE SURGEON ATTEMPTED ALL OF THE REMOVAL PROCEDURE TECHNIQUES WITH NO SUCCESS. THE RED RELEASE BUTTON DID NOT OPEN THE DEVICE DURING THIS ATTEMPT TO REMOVE THE DEVICE. THE SURGEON THEN USED ANOTHER LIKE DEVICE AND FIRED A GREEN RELOAD ON EACH SIDE OF THE LODGED DEVICE TO REMOVE THE STAPLER FROM THE TISSUE. THERE WAS NO BLOOD LOSS REPORTED. THEY WERE VERY CLOSE TO THE ESOPHAGUS AND THEY DO NOT KNOW IF HE FIRED THROUGH THE ESOPHAGEAL TISSUE WHEN CUTTING THE DEVICE OFF. THE PATIENT IS STABLE AT THIS TIME WITH NORMAL POST OP CARE AND DID NOT REQUIRE GOING TO ICU.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 93 MG/DL ON COMPACT PLUS SYSTEM 1 AND 177 MG/DL ON COMPACT PLUS SYSTEM 2 WITHIN 10 MINUTES. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 LONG ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60 MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK NI

    Patients

    Seq Age Sex Outcome Treatment
    1