BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH DILATING TIP TROCAR

    MDR report key: 82060 · Received February 19, 1997

    Report

    Report Number
    9680598-1997-00024
    Event Type
    Malfunction
    Date Received
    February 19, 1997
    Report Date
    February 19, 1997
    Manufacturer
    EES-JUAREZ
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    D5,6; H4: INFO UNAVAILABLE, DEVICE RETURNED WITH NO LOT OR BATCH ID. RESULTS OF EVALUATION: CONCLUSION: BASED ON THE VISUAL EXAMINATION, THE OUTER GASKET OF THE REDUCER CAP IS TORN APPROX. 1/4", BUT NO PIECES WERE PRODUCED. NO CONCLUSION COULD BE REACHED AS TO HOW THE GASKET WAS TORN.

    Description of Event or Problem · 1

    DURING A LAPARSCOPIC CHOLECYSTECTOMY, THE 1SEAL AND 10/11MM TROCAR GASKETS RIPPED. THE SURGEON COMPLETED THE CASE WHILE LOSING PNEUMOPERITONEUM. THE 1SEAL WAS FROM THE FDC32. THERE WAS NO CONSEQUENCE TO THE PT. CLINICAL FOLLOW UP: 1/27/97 1156 MESSAGE AND 800# LEFT FOR MD CALL BACK. 1/27/97 1335 THE SURGEON'S NURSE, CALLED BACK AND STATED THE DIFFICULTY RESULTED FROM THE 1SEAL LEAKING WHENEVER AN INSTRUMENT WAS PUT THROUGH. SHE WAS NOT SURE WHETHER THIS LEAKING WAS A RESULT OF A POOR SEAL AROUND THE INSTRUMENT OR A TEAR. SHE DID NOT RECALL DIFFICULTY WITH THE TROCAR ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH DILATING TIP TROCAR TROCAR GCJ EES-JUAREZ NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other