BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH THORACIC ENDO LINEAR CUTTER W/SAFETY LOCK

    MDR report key: 89911 · Received May 7, 1997

    Report

    Report Number
    1527736-1997-00864
    Event Type
    Malfunction
    Date Received
    May 7, 1997
    Date of Event
    April 7, 1997
    Report Date
    May 7, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    H6; CODE 400: STAPLE FORM, APPEARED TO BE EXCESSIVE "B" FORM HEIGHT. FACILITY EXPERIENCED AN EVENT WITH THE ENDOPATH THORACIC ENDOSCOPIC LINEAR CUTTER WITH SAFETY LOCK WHILE PERFORMING A LUNG BIOPSY. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #972377. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: LOCKOUT POSITION, FIRED; CARTRIDGE CONDITION, 3/4 FIRED; CARTRIDGE RETURN BATCH NUMBER, K00R95; AND INSTRUMENT NUMBER, 0208. FUNCTIONAL TESTS & RESULTS: CONDITION OF FIRING TRIGGER LOCKOUT, CONDITION OF PINION GEAR, CONDITION OF SHORT RACK, AND CONDITION OF YOKE, GOOD; AND WAS INSTRUMENT CYCLED, YES. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FIRED, AND CUT PROPERLY, BUT DID NOT FORM THE STAPLES WITHIN DESIGN SPECIFICATION. NO CONCLUSION COULD BE REACHED AS TO WHY THE STAPLES DID NOT FORM PROPERLY. 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 THE PRODUCTS.

    Description of Event or Problem · 1

    DURING A LUNG BIOPSY PROCEDURE, IT WAS REPORTED BY THE AFFILIATE THAT THE STAPLES WERE FIRED INTO TISSUE BUT DID NOT FORM. THE JAWS THAN OPENED PRIOR TO BUTTON BEING PUSHED. STAPLES WERE REMOVED WITH GRASPERS. A NEW DEVICE WAS USED TO COMPLETE THE RESECTION. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH THORACIC ENDO LINEAR CUTTER W/SAFETY LOCK ENDOSCOPIC LINEAR CUTTER GAG ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other