BEUDAMED
    FDA Adverse Event Other Summary report: N

    PASSPORT TROCAR

    MDR report key: 2508674 · Received March 20, 2012

    Report

    Report Number
    1651380-2012-00001
    Event Type
    Other
    Date Received
    March 20, 2012
    Date of Event
    January 26, 2012
    Report Date
    February 22, 2012
    Manufacturer
    PATTON SURGICAL CORP.
    Product Code
    GCJ
    PMA / PMN Number
    K080161
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL UNITS TESTED WERE IN ORIGINAL, SINGLE UNIT, UNOPENED PACKAGES. TWO DYNAMIC COMPRESSIVE TESTS WERE PERFORMED. EACH CANNULA TUBE ASSEMBLY WAS SECURED INTO A TEST FIXTURE, AT 30 DEGREES RELATIVE TO VERTICAL AND FORCE WAS APPLIED AT A RATE OF 11 IN/MIN AT TWO LOCATIONS ALONG THE CANNULA TUBE; NINETY DEGREES RELATIVE TO EACH OTHER, AND USING A CHARTILLON PCM 2001 AND BG100RT LOAD CELL. THIS TEST DID NOT PRODUCE SHATTERED OR BROKEN TROCARS AS REPORTED. THE SECOND TEST EVALUATED PERCENT DEFORMATION OF THE DISTAL TIP. UNITS WERE COMPRESSED TO 30%, 50% AND 70% OF ORIGINAL INNER DIAMETER, CYCLED TEN TIMES, AND ROTATED NINETY DEGREES, CYCLES AND COMPRESSED AGAIN TO THE SAME PERCENTAGE DEFORMATION. UNITS WERE INSPECTED FOR BREAKAGE AND CRACKING. THIS TEST DID NOT PRODUCE SHATTERED OR BROKEN TROCARS AS REPORTED. ALL PRODUCT EVALUATED MET PRODUCT PERFORMANCE STANDARDS. ADDITIONALLY, ALL PASSPORT TROCARS ARE COMPLAINT WITH ISO 10993 BIOCOMPATIBILITY REQUIREMENTS FOR A LAPAROSCOPIC INSTRUMENT. DETAILED TEST DATA IS ON FILE AT PATTON SURGICAL CORPORATION.

    Description of Event or Problem · 1

    TITLE: XXXXX. EVENT DESC: A 12MM HASSON TROCAR FOR THE LAPAROSCOPIC DAVINCI CASE FRACTURED. THE SHAFT OF THE TROCAR SHATTERED WHILE THE TROCAR WAS INSIDE OF THE PT. THE TIP OF THE TROCAR BROKE OFF INTO THREE PIECES, TWO OF WHICH WERE RECOVERED FROM THE PT. THE THIRD PIECE WAS NOT FOUND. BOTH SUTURE ANCHORS ON THE HASSON PART OF THE TROCAR BROKE OFF AND LOOSENED THE SUTURE FROM THE TROCAR AS WELL. MFR RESPONSE FOR 12MM X 15MM HASSON TROCAR, PATTON TROCAR (PER SITE REPORTER). WILL INVESTIGATE. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? DAVINCI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PASSPORT TROCAR 12MM X 150MM HASSON TROCAR GCJ PATTON SURGICAL CORP. 12150EB-11 6202-01

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other