BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45 MM STAPLE LINE - 4

    MDR report key: 1021972 · Received March 14, 2008

    Report

    Report Number
    1527736-2008-01541
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    February 15, 2008
    Report Date
    February 19, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DAMAGED CLAMPING MECHANISM. EVALUATION SUMMARY: THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED WITH THE ANVIL IN THE CLOSED POSITION AND WITH A CARTRIDGE LOADED IN THE DEVICE. THE CARTRIDGE WAS RECEIVED VOID OF STAPLES, WITH THE LOCKOUT DAMAGED AND WAS NOTED TO HAVE BUTTRESSING MATERIAL ON THE CARTRIDGE DECK. THE DAMAGE OF THE CARTRIDGE LOCKOUT TAB IS CONSISTENT WITH DAMAGE OBSERVED WHEN THE TRYING TO FIRE AN ALREADY SPENT CARTRIDGE. THE DEVICE WAS NOTED TO HAVE THE CLAMPING MECHANISM DAMAGED, AS THE DEVICE WOULD ONLY OPEN IF REVERSE FORCE WAS APPLIED. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST CARTRIDGE AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. IN ADDITION, THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE YOKE WAS FOUND DAMAGED WERE IT ENGAGES WITH THE TUBE, NOT ALLOWING THE DEVICE TO PROPERLY OPEN. ALTHOUGH NO CONCLUSION COULD BE REACHED AS TO HOW THE YOKE BECAME DAMAGED, THIS DAMAGE CAN OCCUR WHEN EXCESSIVE FORCE IS APPLIED TO THE CLOSING TRIGGER WHEN THE JAWS ARE CLAMPED ON TISSUE THICKER THAN INDICATED. IN ADDITION, IT SHOULD BE NOTED THAT AT LEAST A 100% INSPECTION TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT FGQA. WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITION, COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. 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 LAP COLON PROCEDURE, COULD NOT OPEN THE DEVICE AFTER THE FIRST FIRING. THE DEVICE HAD TO BE CUT OUT. THE SURGEON HAD TO CUT OUT CA. 2 CM. THERE WASN'T ANY HARM TO THE PATIENT. THE SURGERY WAS PROLONGED BETWEEN 30 AND 40 MINUTES. THE PATIENT WAS AND IS IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45 MM STAPLE LINE - 4 GDW ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention