BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL* BLADELESS TROCAR WITH STABILITY SLEEVE

    MDR report key: 1770767 · Received July 27, 2010

    Report

    Report Number
    3005075853-2010-04230
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    June 29, 2010
    Report Date
    June 29, 2010
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DAMAGED DUCKBILL. THE ANALYSIS RESULTS FOUND THAT DEVICE (A) WAS RECEIVED WITH THE DUCKBILL SEAL OPEN AT THE SLIT. AS A RESULT, IT WOULD NOT OPEN AND CLOSE AS INTENDED; LEADING THE REPORTED INSUFFLATIONS ISSUES. A POTENTIAL CAUSE OF THIS FAILURE IS ATTRIBUTED TO MOLDING, COMPONENT TRANSIT, BODILY FLUIDS OR DEBRIS FROM SURGERY. AS EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING THE MANUFACTURING PROCESS, NO CONCLUSION COULD BE REACHED AS TO WHAT MIGHT HAVE CAUSED THE REPORTED EVENT. THE ANALYSIS RESULTS FOUND THAT DEVICE (B) WAS RECEIVED WITH THE DUCKBILL SEAL OPEN AT THE SLIT. AS A RESULT, IT WOULD NOT OPEN AND CLOSE AS INTENDED; LEADING THE REPORTED INSUFFLATIONS ISSUES. A POTENTIAL CAUSE OF THIS FAILURE IS ATTRIBUTED TO MOLDING, COMPONENT TRANSIT, BODILY FLUIDS OR DEBRIS FROM SURGERY. AS EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING THE MANUFACTURING PROCESS, NO CONCLUSION COULD BE REACHED AS TO WHAT MIGHT HAVE CAUSED THE REPORTED EVENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4) INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S NEPHRECTOMY PROCEDURE WHILE USING THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WITH THE TIP COVER ACCESSORY INSTALLED, UNINTENDED ARCING WAS SEEN. THE TIP COVER WAS IMMEDIATELY REMOVED AND REPLACED AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICES ARE NOT LONG ENOUGH. BOTH DEVICES WERE LEAKING THROUGHOUT THE CASE BETWEEN THE HOUSING AND THE SEAL CAP. THE SAME DEVICES WERE USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1