BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 LONG

    MDR report key: 1821826 · Received August 31, 2010

    Report

    Report Number
    3005075853-2010-04984
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 6, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT ONE (B)(4) DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITHOUT CARTRIDGE RELOAD PRESENT. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE FIRING SEQUENCE. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. AFTER FURTHER ANALYSIS THE KNIFE WAS NOTED TO BE DAMAGED. ONE POSSIBLE CAUSE FOR THIS TYPE OF DAMAGE TO THE KNIFE IS WHEN THE DEVICE IS FIRED OVER AN ALREADY EXISTING STAPLE LINE, HARD OBJECT OR THICKER TISSUE THAN INDICATED. REPEATEDLY FIRING ACROSS EXISTING STAPLE LINES CAN ALSO REDUCE THE ABILITY TO CUT CLEANLY. 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. IN ADDITION, THE FIRING TRIGGER WAS NOT WORKING PROPERLY ON EACH STROKE AS THE PAWL WAS NOT ENGAGING WITH THE DRIVE BAR AT REPEATED ATTEMPTS. THE DEVICE WAS DISASSEMBLED TO VERIFY THE INTERNAL COMPONENTS AND WEAR WAS FOUND ON THE RIGHT SIDE OF THE CLOSURE TRIGGER DUE TO THE CLAMP FIRST LOCKOUT PIN ON THE GEARED TRIGGER PLATE. ONE POSSIBLE SCENARIO FOR THE DESCRIBED EVENT IS DUE TO APPLYING A PRYING FORCE ON THE CLOSURE TRIGGER HANDLE IN THE OPENING DIRECTION. THIS CAN THEN RESULT IN DAMAGE TO THE CLOSURE TRIGGER TOP COMPONENT IF THE APPLIED LOAD IS HIGH ENOUGH. ONCE THE CLOSURE TRIGGER TOP COMPONENT IS DAMAGED, THEN ANY ADDITIONAL ACTUATION OF THE FIRING TRIGGER CAN CAUSE IT TO RUB AGAINST THE NOW BROKEN OR BENT CLOSURE TRIGGER ASSEMBLY. 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). THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    AS PUBLISHED IN NEUROSURGERY 67:E516-E517, 2010 IN "EARLY MIGRATION OF A SELF EXPANDING INTRACRANIAL STENT: CASE REPORT." THE PATIENT PRESENTED WITH SUBARACHNOID HEMORRHAGE SECONDARY TO A SMALL DISTAL BASILAR TRUNK ANEURYSM. UNDER GENERAL ANESTHESIA AND SYSTEMIC HEPARINIZATION, AN ENTERPRISE STENT (4.5 X 14 MM) WAS DEPLOYED ACROSS THE NECK OF THE BASILAR TRUNK ANEURYSM TO ACHIEVE FLOW REMODELING. THE STENT WAS POSITIONED WITH THE DISTAL MARKERS JUST PROXIMAL TO THE SUPERIOR CEREBELLAR ARTERIES (SCAS) AND THE PROXIMAL MARKERS JUST DISTAL TO THE ANTERIOR INFERIOR CEREBELLAR ARTERIES. POST-PROCEDURE ANGIOGRAMS DEMONSTRATED THAT THE SMALL BASILAR TRUNK ANEURYSM STILL WAS FILLING. A REPEAT ANGIOGRAM WAS CARRIED OUT 2 DAYS LATER, WITH A VIEW OF FURTHER STENTING IF THE ANEURYSM WAS STILL PATENT. SURPRISINGLY, IT SHOWED THAT THE STENT HAD MIGRATED PROXIMALLY BELOW THE LEVEL OF THE ANEURYSM. THE DISTAL MARKERS WERE NOW AT THE LEVEL OF THE MID-BASILAR ARTERY, WITH THE PROXIMAL MARKERS JUST DISTAL TO THE BASILAR ORIGIN. THE ANEURYSM WAS STILL FILLING. A SECOND, OVERLAPPING ENTERPRISE STENT (4.5 X 22 MM) WAS DEPLOYED FROM THE LEFT P1 SEGMENT INTO THE BASILAR ARTERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, THE SURGEON NOTICED THAT DURING THE FIRST STAPLING, THE DEVICE WAS HARD TO FIRE. DURING THE SECOND FIRING, THE BLADE PUSHED THE TISSUE OUTSIDE THE JAWS WHICH CREATED A BAD STAPLING FORMATION ON 2CM. THE DEVICE WAS REPLACED BY ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 LONG STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4T75T

    Patients

    Seq Age Sex Outcome Treatment
    1