BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH CURVED SCISSORS

    MDR report key: 93318 · Received May 22, 1997

    Report

    Report Number
    1527736-1997-01006
    Event Type
    Malfunction
    Date Received
    May 22, 1997
    Date of Event
    April 23, 1997
    Report Date
    May 22, 1997
    Manufacturer
    SYMBIOSIS CORP.
    Product Code
    KNS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY EXPERIENCED AN EVENT WITH ENDOPATH* CURVEC SCISSORS ON 4/23/97 WHILE PERFORMING A LAP NISSEN FUNDOPLICATION. THE PRODUCT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY # 972572. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: HANDLE CONDITION, GOOD, SCISSORS CONDITION, GOOD AND SHAFT CONDITION, GOOD. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE INSTRUMENT WAS RETURNED WITH A SPLIT IN THE INSULATION AT THE DISTAL END OF THE SHAFT. NO FUNCTIONAL TESTING WAS PERFORMED DUE TO THE CONDITION OF THE INSTRUMENT RETURNED. NO CONCLUSION COULD BE REACHED AS TO HOW THE INSTRUMENT HAD BECOME DAMAGED. 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 LAPAROSCOPIC NISSEN FUNDOPLICATION THE DCS12 INSULATION DOWN BY THE SHOULDERS SPLIT AND THE SURGEON WAS AFRAID TO USE THE INSTRUMENT DUE TO THE POTENTIAL ARCING OF ELECTRICITY. THE CASE WAS COMPLETED WITH THE HARMONIC SCALPEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH CURVED SCISSORS SCISSORS KNS SYMBIOSIS CORP. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other