BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTER

    MDR report key: 122036 · Received September 24, 1997

    Report

    Report Number
    1527736-1997-02357
    Event Type
    Injury
    Date Received
    September 24, 1997
    Date of Event
    August 26, 1997
    Report Date
    August 26, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DAMAGED FIRING MECHANISM. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW: VISUAL INSPECTIONS & RESULTS: LOCKOUT POSITION, FIRED; CARTRIDGE CONDITION, 1/2 FIRED; CARTRIDGE RETURN BATCH NUMBER, EM0186; CONDITION OF KNIFE, NICKED AND INSTRUMENT NUMBER, 284. FUNCTIONAL TESTS & RESULTS: CONDITION OF FIRING TRIGGER LOCKOUT, GOOD; CONDITION OF PINION GEAR, DAMAGED; CONDITION OF SHORT RACK, BROKEN AND CONDITION OF YOKE, GOOD. ANALYSIS CONCLUSION: BASED UPON THE INFO REC'D AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENT WAS RETURNED WITH TISSUE IN THE JAWS THAT HAD A CLIP LAYING ACROSS THE CARTRIDGE KNIFE SLOT. IT WAS CONCLUDED THAT THE CLIP CAUSED THE INSTRUMENT TO STOP FIRING. THE INSTRUMENT WAS RETURNED WITH A BROKEN SHORT RACK, DAMAGED PINION GEAR TEETH, AND A NICKED KNIFE. IT WAS CONCLUDED THAT THE CLIP LAYING ACROSS THE CARTRIDGE CAUSED THE INSTRUMENT TO BECOME DAMAGED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE CO'S PRODUCTS.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A BLADDER AUGMENTATION. IT WAS REPORTED THE JAWS OF THE EZ35W WERE CLOSED. WHEN THE SURGEON WENT TO FIRE, A POPPING SOUND WAS HEARD AND THE FIRING SEQUENCE WAS CONTINUED. THE THE JAWS WOULD NOT OPEN, AND THE CASE WAS CONVERTED TO AN OPEN PROCEDURE TO EXISE THE DEVICE. DEVICE BEING RETURNED WITH JAWS IN CLOSED POSITION. THIS OCCURED ON FIRST FIRING OF DEVICE. 9/4/97 RISK MANAGER, CALLED BACK AND STATED HE WILL INVESTIGATE THE EVENT AND FORWARD INFO AS IT BECOMES AVAILABLE. HE STATED HE WOULD CHECK WITH THE CLINICAL ENGINEERING DEPT TO SEE IF THEY HAVE DONE A MEDWATCH FORM. EES FAX NUMBER PROVIDED. 9/12/97 1411 RISK MANAGER, CALLED BACK AND STATED THEY WILL NOT BE SUBMITTING MEDWATCH AS PT DID WELL AND THERE ARE NO PT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTER ENDOSCOPIC LINEAR CUTTER GAG ETHICON ENDO-SURGERY, INC. NA H40966

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other