BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH

    MDR report key: 6873393 · Received September 18, 2017

    Report

    Report Number
    3005075853-2017-05008
    Event Type
    Malfunction
    Date Received
    September 18, 2017
    Report Date
    August 25, 2017
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT DESCRIPTION CONTINUED: (AL) WAS VULNERABLE TO EXCESSIVE ROTATION, CREATING MISALIGNMENT OF THE CLOSURE SYSTEM. THIS FACT EXPLAINED WHY THE TWO EVENTS TOOK PLACE. TO AVOID STAPLE MALFORMATION, THE AL SHOULD NOT BE ROTATED BEYOND ITS LIMIT OF MOBILITY. ONCE THE AL IS ROTATED TO ITS FULLEST WITH GENTLE HANDLING, ONE SHOULD NOT ATTEMPT TO ROTATE FURTHER WITH EXCESSIVE FORCE. THIS ATTEMPT MAY DISINTEGRATE THE AL, CAUSING MISALIGNMENT OF THE ANVIL FORK AND THE CARTRIDGE FORK, LEADING INTO STAPLING FAILURE. THE BATCH/LOT NUMBER IS UNKNOWN. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCES.

    Description of Event or Problem · 1

    PREVENTING A PITFALL: NO-KNIFE STAPLERS THAT REQUIRE CAUTION DURING HANDLING. CITATION: GENERAL THORACIC AND CARDIOVASCULAR SURGERY 2010;58:306-307. DOI 10.1007/S11748-009-0560-8. IT WAS REPORTED VIA JOURNAL ARTICLE: IN 2007, THE AUTHORS REPORTED THE SAFETY EFFICACY OF A NO-KNIFE (NK) STAPLER (NAW ENDOPATH FLEX 45 NO KNIFE ENDOSCOPIC LINEAR STAPLER) TO BE USED AT THE TIME OF VASCULAR DIVISION. SINCE THEN, THEY HAVE USED THIS DEVICE DURING 177 SESSIONS IN 156 PATIENTS AND NOTED 2 INCIDENCES WHERE SEVERAL OF THE STAPLES WERE MALFORMED. THIS ARTICLE REPORTS ITS MECHANISM AND NOTE THE PRECAUTIONS NEEDED TO AVOID THIS EVENT. THE 2 INCIDENCES OCCURRED WHEN DIVIDING PULMONARY VESSELS DURING THE SECOND SESSION USING THE SAME NK STAPLER. SEVERAL OF THE STAPLES, WHICH WERE MOST DISTAL TO THE JAW OF THE NK STAPLER AND BEYOND THE VESSEL WERE MALFORMED OR SCATTERED IN THE THORAX. WHEN THE MALFORMED PART OF THE STAPLE LINE WAS INCISED, BLEEDING OCCURRED BUT WAS IMMEDIATELY CONTROLLED; THE REMAINING VESSEL WAS TIED AND WAS DIVIDED WITHOUT EVENT. A CLOSE INVESTIGATION REVEALED THAT THE DEVICE REPRODUCED STAPLE MALFORMATION. THE INVESTIGATION SHOWED THAT THE ARTICULATION LEVER (AL) WAS VULNERABLE TO EXCESSIVE ROTATION, CREATING MISALIGNMENT OF THE CLOSURE SYSTEM. THIS FACT EXPLAINED WHY THE TWO EVENTS TOOK PLACE. TO AVOID STAPLE MALFORMATION, THE AL SHOULD NOT BE ROTATED BEYOND ITS LIMIT OF MOBILITY. ONCE THE AL IS ROTATED TO ITS FULLEST WITH GENTLE HANDLING, ONE SHOULD NOT ATTEMPT TO ROTATE FURTHER WITH EXCESSIVE FORCE. THIS ATTEMPT MAY DISINTEGRATE THE AL, CAUSING MISALIGNMENT OF THE ANVIL FORK AND THE CARTRIDGE FORK, LEADING INTO STAPLING FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652383 ENDOPATH STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1