BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH THORACIC ENDO LINEAR CUTTER W/SAFETY LOCK

    MDR report key: 140372 · Received December 23, 1997

    Report

    Report Number
    1527736-1997-03604
    Event Type
    Malfunction
    Date Received
    December 23, 1997
    Date of Event
    November 27, 1997
    Report Date
    November 27, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE-A PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF DEVICE WHICH WAS RETURNED. RESULTS OF INVESTIGATION CONDUCTED BY APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: LOCKOUT POSITION, N/A; CARTRIDGE CONDITION, N/A AND CARTRIDGE RETURN BATCH NUMBER, N/A. FUNCTIONAL TESTS & RESULTS: CONDITION OF FIRING TRIGGER LOCKOUT, AB GOOD; CONDITION OF PINION GEAR, AB GOOD; CONDITION OF SHORT RACK, AB GOOD; CONDITION OF YOKE, AB GOOD AND TEST CARTRIDGE BATCH #, AB K01142. ANALYSIS CONCLUSION: BASED UPON INQUIRY INFO RECEIVED, VISUAL EXAMINATION, AND FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY INSTRUMENTS REPORTEDLY "DID NOT WORK PROPERLY" DURING SURGERY. INSTUMENTS WERE RETURNED IN GOOD PHYSICAL CONDITION. INSTRUMENTS WERE CYCLED, FIRED, CUT AND FORMED STAPLES WITHIN DESIGN SPECIFICATION. SHAFT ROTATATION WAS CONFORMING AND JAW OPENING WAS CONFORMING WHEN TESTED. INSTRUMENTS WERE DISASSEMBLED TO EXAMINE INTERNAL COMPONENTS AND NO DEFORMATIONS COULD BE IDENTIFIED. IT WAS CONCLUDED THAT INSTRUMENTS WERE FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECIFICATIONS. EXPERIENCE SURGEON REPORTED COULD NOT BE REPEATED. EACH INSTRUMENT IS EVALUATED DURING ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICES WERE USED DURING A THORACOSCOPIC LUNG BIOPSY PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE DEVICE DID NOT WORK PROPERLY. THE JAWS OF THE FIRST DEVICE DID NOT OPEN PROPERLY WHEN RELEASE BUTTON WAS PUSHED. THE SHAFT OF THE SECOND DEVICE ROTATES MUCH TOO FREELY (CAN NOT BE POSITIONED ON THE TISSUE).

    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 K47J1L

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other