BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH THORACIC ENDOSCOPIC LINEAR CUTTER RELOAD

    MDR report key: 82146 · Received February 20, 1997

    Report

    Report Number
    1527736-1997-00072
    Event Type
    Malfunction
    Date Received
    February 20, 1997
    Date of Event
    January 24, 1997
    Report Date
    February 20, 1997
    Manufacturer
    EES-CINCINNATI
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    D6: DEVICE RETURNED WITH NO LOT ID AND UNABLE TO IDENTIFY BATCH NUMBER AFTER THE ANALYSIS. FOUR CARTRIDGES RETURNED, ALL WITH THE SAME ANALYSIS RESULTS "CARTRIDGES RETURNED EMPTY, NO FUNCTIONAL TESTING PERFORMED." VISUAL INSPECTIONS & RESULTS: LOCKOUT POSITION; ABCDEFG FIRED. CARTRIDGE CONDITION; ABCDEFG FULLY FIRED. CARTRIDGE RETURN BATCH NUMBER; ABC J0079F D H00. FUNCTIONAL TESTS & RESULTS: CONDITION OF PINION GEAR, CONDITION OF SHORT RACK, CONDITION OF YOKE. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE CARTRIDGES WERE RETURNED FULLY FIRED AND IN GOOD PHYSICAL CONDITION. NO TESTING COULD BE PERFORMED AS THE CARTRIDGES WERE RETURNED FULLY FIRED.

    Description of Event or Problem · 1

    DURING A THORACOSCOPY, THE FIRST TWO FIRINGS OF THE DEVICE WORKED FINE. THE DEVICE WAS RELOADED WITH CARTRIDGE ZR45G THE DEVICE CUT BUT DID NOT STAPLE. THERE WAS BLEEDING ALONG THE SAPLE LINE AND A CLIP APPLIER WAS USED TO LIGATE VESSELS. ANOTHER RELOAD ZR45G WAS USED IN THE DEVICE AND WORKED FINE. NO BUTTREESING MATERIAL WAS USED. REP IS RETURNING SEVERAL RELOADS AND IS NOT SURE WHICH RELOAD DID NOT WORK. THERE WAS NO CONSEQUENCE TO THE PT. CLINICAL FOLLOW UP: 1/28/97 1405 SPOKE WITH THE SURGEON. HE STATED THE DEVICE WAS USED TWICE TO A WEDGE RESECTION. THE PROCEDURE PROGRESSED TO A SEGEMENTECTOMY FOR A LEFT UPPER LOBE TUMOR. ON THE THIRD FIRING IT WAS USED TO TAKE DOWN THE FISSURE IN THE APICAL SEGMENT ON THE LEFT LUNG. ON THE FOURTH FIRING OF THE DEVICE IT CUT BUT FORMED APPROX A HALF A DOZEN STAPLES IN THE MIDDLE THIRD OF THE STAPLE LINE. THERE WERE NO OTHER STAPLES PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH THORACIC ENDOSCOPIC LINEAR CUTTER RELOAD ENDOSCOPIC LINEAR CUTTERS GAG EES-CINCINNATI NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other