BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL* TROCAR

    MDR report key: 2250617 · Received September 16, 2011

    Report

    Report Number
    3005075853-2011-03823
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    August 23, 2011
    Report Date
    August 25, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED WITH THE OBTURATOR CANNULA BENT. A POTENTIAL CAUSE OF THIS DAMAGE IS THE APPLICATION OF AN EXCESSIVE FORCE ON THE OBTURATOR OVER THE SLEEVE ASSEMBLY AREA THAT CAUSES THE OBTURATOR TO BECOME BENT DURING TRANSIT. HOWEVER, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY CAUSED THE FOUND DAMAGE. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE OBTURATOR COULD NOT BE SET INTO THE OUTER SLEEVE, BECAUSE THE OBTURATOR WAS BENT BEFORE USE IN THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** XCEL* TROCAR LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA H44032

    Patients

    Seq Age Sex Outcome Treatment
    1