BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH DILATING TIP TROCAR

    MDR report key: 84938 · Received April 15, 1997

    Report

    Report Number
    9680598-1997-00084
    Event Type
    Malfunction
    Date Received
    April 15, 1997
    Date of Event
    January 7, 1997
    Report Date
    April 8, 1997
    Manufacturer
    EES-JUAREZ
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF EVALUATION: CONCLUSION; THE INSTRUMENT (A) WAS CYCLED AND IT FAILED TO ARM. THE KNIFE COLLAR IS SLIGHTLY BENT. INSTRUMENT B WAS ALSO BENT AT THE KNIFE COLLAR. THE KNIFE COLLAR HAS EXCESS MATERIAL THAT COULD POSSIBLY PREVENT THE LATCH FROM FUNCTIONING. THIS TYPE OF OCCURRANCE IS UNUSUAL AND WILL BE MONITORED CLOSELY. COMMENTS; CO REVIEWS EACH INCIDENT AS IT OCCURS IN AN EFFORT TO CONTINOUSLY IMPROVE OUR PRODUCTS.

    Description of Event or Problem · 1

    DURING A DIAGNOSTIC LAPAROSCOPY THE SURGEON WAS USING A 512SD TROCAR AND COULD NOT GET THE SAFETY MECHANISM TO STAY DOWN DURING INSERTION. A SECOND DEVICE WAS OPENED AND HAD THE SAME PROBLEM OCCUR. A THIRD DEVICE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO CONSEQUNCE TO THE PT. 01/15/97 1100 MESSAGE AND 800# LEFT WITH RECEPTIONIST FOR MD CALL BACK. 1/16/97 NNCL SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH DILATING TIP TROCAR TROCAR GCJ EES-JUAREZ NA J45A3C

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other