BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTER

    MDR report key: 39927 · Received September 10, 1996

    Report

    Report Number
    1527736-1996-00121
    Event Type
    Malfunction
    Date Received
    September 10, 1996
    Date of Event
    August 7, 1996
    Report Date
    September 10, 1996
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: BASED UPON THE INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENT WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS DISASSEMBLED AND FOUND TO HAVE A DAMAGED FIRING MECHANISM. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. SOME CONDITIONS WHICH MIGHT RESULT IN DAMAGE TO THE FIRING MECHANISM ARE: INTERRUPTED FIRING CYCLE, TISSUE THICKER THAN INDICATED, ATTEMPTING TO FIRE THROUGH A SPENT CARTRIDGE, FIRING PRIOR TO COMPLETE CLAMPING OF THE JAWS AND FAILURE TO PROPERLY FOLLOW RELOADING INSTRUCTIONS.

    Description of Event or Problem · 1

    ON 8/15/96 0906 MESSAGE AND 800# LEFT FOR MD CALL BACK. TSB. 8/15/96 1545 SURGEON RETURNED CALL AND STATED THE EZ35 FIRED CORRECTLY ON THE FIRST FIRING. ON THE SECOND FIRING, IT WOULD NOT CLOSE. THE SURGEON REMOVED THE DEVICE FROM THE BODY AND OPENED AND ATTEMPTED TO CLOSE THE DEVICE OUTSIDE THE BODY. IT WOULD NOT CLOSE. THE CASE WAS COMPLETED WITH SCISSORS AND ELECTROCAUTERY. KJB. 8/20/96 1230 CIN ATTEMPTED TO REACH CONTACT, AND WAS TOLD HE WOULD BE IN TOMORROW. BAH. 8/20/96 1235 COURTESY RISK MANAGER. SHE WILL TRY TO OBTAIN PATIENT INFORMATION. BAH. 8/21/96 1520 ATTEMPTED TO REACH CONTACT, HE LEFT FOR THE DAY. TKB. 8/22/96 1008 CONTACT REPORTED THE SURGEON WAS HAVING TROUBLE GETTING THE INSTRUMENT TO STAY CLOSED. SHE FINALLY GOT THE INSTRUMENT TO STAY CLOSED AND FIRED WITHOUT DIFFICULTY. ON A SUBSEQUENT RELOAD, THE JAWS WOULD NOT OPEN WITHOUT PRYING THEM OPEN AFTER INSERTING INSTRUMENT IN TROCAR. THEN IT WOULD NOT FIRE AT ALL. HE COULD NOT REMEMBER HOW THE INSTRUMENT WAS COMPLETED. PATIENT INFO AS FOLLOWS: EAB, MR #114695, DOB 1-27-1970, FEMALE, UNK WEIGHT. TSB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTER LINEAR CUTTER GAG ETHICON ENDO-SURGERY, INC. NA J43825

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other