BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTER

    MDR report key: 84725 · Received April 14, 1997

    Report

    Report Number
    1527736-1997-00590
    Event Type
    Malfunction
    Date Received
    April 14, 1997
    Date of Event
    March 6, 1997
    Report Date
    April 11, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY EXPERIENCED AN EVENT WITH ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTER ON 3/6/97 WHILE PERFORMING A LAPAROSCOPY. THE PRODCUT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY # 971673. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: CARTRIDGE CONDITION, A UNFIRED B FIRED; CARTRIDGE RETURNED BATCH NUMBER, A EM0088 B EM0; CONDITION OF KNIFE, GOOD; CONDITION OF WEDGES, GOOD; FIRING HANDLE CONDITION, GOOD; IS KNIFE PRESENT, YES; LOCKOUT INDICATOR, A UNFIRED B FIRED AND STAPLES PRESENT IN INSTRUMENT, NO. FUNCTIONAL TESTS & RESULTS: WAS INSTRUMENT CYCLED, YES. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO REC'D, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY "MISFIRED" DURING SURGERY. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED WITH THE RETURNED CARTRIDGE, FIRED, CUT, AND FORMED THE STAPLES WITHIN DESIGN SPEC. IT WAS CONCLUDED THAT THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. 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. WE APPRECIATE THE FACT THAT YOU TOOK THE TIME TO INFORM US OF THE EVENT. YOUR INFO IS A DRIVING FORCE IN OUR CONTINUOUS IMPROVEMENT PROCESS.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC COLON PROCEDURE IT WAS REPORTED THE SURGEON WENT TO FIRE THE EVC35 AND IT MISFIRED. THE DEVICE CUT, BUT DID NOT STAPLE. THE SURGEON HAD TO CONVERT TO OPEN PROCEDURE. 03/28/1997 1450 HOSP REP CALLED BACK AND STATED THEY HAVE DETERMINED VIA THEIR INVESTIGATION THIS IS NOT A REPORTABLE EVENT. SHE STATED SHE SPOKE WITH THE SURGEON WHO TOLD HER THIS CASE WOULD HAVE BEEN CONVERTED TO AN OPEN PROCEDURE REGARDLESS OF THE INSTRUMENT PERFORMANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTER ENDOSCOPIC VASCULAR LINEAR CUT GAG ETHICON ENDO-SURGERY, INC. NA GC02EL

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other