BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ETS

    MDR report key: 82135 · Received February 27, 1997

    Report

    Report Number
    1527736-1997-00084
    Event Type
    Malfunction
    Date Received
    February 27, 1997
    Date of Event
    January 22, 1997
    Report Date
    February 27, 1997
    Manufacturer
    EES-CINCINNATI
    Product Code
    KOG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHY THE INSTRUMENT REPORTEDLY "CUT BUT DID NOT STAPLE" DURING SURGERY. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FIRED, CUT, AND FORMED THE STAPLES WITHIN DESIGN SPEC. THE INSTRUMENT WAS DISASSEMBLED TO EXAMINE THE INTERNAL COMPONENTS AND NO DEFORMATIONS COULD BE IDENTIFIED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. COMMENTS: EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IF FUNCTIONS PROPERLY.

    Description of Event or Problem · 1

    THE INSTRUMENT WAS USED DURING A LAPAROSCOPY. IT WAS REPORTED ON THE 2ND AND 4TH FIRINGS, THE INSTRUMENT CUT BUT DID NOT STAPLE. ANOTHER TSW35 WAS USED TO FINISH THE CASE. THERE WAS NO CONSEQUENCE TO THE PT. CLINICAL FOLLOW UP: 2/3/97 1650 MESSAGE AND 800 NUMBER LEFT FOR SURGEON TO CALL BACK. 2/3/97 THE SURGEON RETURNED CALL. HE STATED THE DEVICE WOULD NOT FIRE, WOULD NOT OPEN, AND CUT BUT DID NOT STAPLE ON THREE DIFFERENT FIRINGS. HE COULD NOT REMEMBER ON WHICH FIRINGS THESE OCCURRED AND COULD NOT REMEMBER THE EXACT SPECIFICS OF THE EVENT. THE SURGEON STATED THE DEVICE DOES NOT FEEL GOOD IN HIS HANDS AND DOES NOT FEEL COMFORTABLE TO HOLD. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other