BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS

    MDR report key: 82145 · Received February 27, 1997

    Report

    Report Number
    1527736-1997-00083
    Event Type
    Malfunction
    Date Received
    February 27, 1997
    Date of Event
    January 29, 1997
    Report Date
    February 27, 1997
    Manufacturer
    EES-CINCINNATI
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    H6; CODE 200: LOCKOUT TABS BENT AS IF FIRED, RELEASE, AND REFIRED. RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT BOTH CARTRIDGES WERE RETURNED WITH BENT LOCKOUT TABS ON THE PAN WHICH INDICATES THAT THE INSTRUMENT'S FIRING CYCLE WAS INTERRUPTED, RELEASED, THEN RESTARTED. NO TESTING COULD BE PERFORMED DUE TO THE CONNECTION OF THE CARTRIDGES RETURNED. COMMENTS: IF THE INSTRUMENT'S FIRING CYCLE IS INTERRUPTED, RELEASED, THEN RESTARTED, THE INSTRUMENT AND CARTRIDGE MAY BECOME DAMAGED.

    Description of Event or Problem · 1

    THE INSTRUMENT WAS USED DURING A LAVH. IT WAS REPORTED ON THE 3RD AND 5TH FIRING OF THE TSW35 THE STAPLER WOULD NOT FIRE. ANOTHER TSW35 WAS USED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT. CLINICAL FOLLOW UP: 2/4/97 1350 MESSAGE AND 800 NUMBER LEFT FOR SURGEON TO CALL BACK. 2/5/97 1715 NNCL SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS LINEAR CUTTER GAG EES-CINCINNATI NA J45D9K

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other