BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL* DILATING TIP TROCAR

    MDR report key: 2931546 · Received January 28, 2013

    Report

    Report Number
    3005075853-2013-00337
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    December 3, 2012
    Report Date
    December 3, 2012
    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).

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. WE WERE UNABLE TO ANALYZE THE SAMPLE UTILIZED IN THE REPORTED EVENT AS THE INSTRUMENT WAS NOT RETURNED TO US. THERE WAS A PHOTOGRAPH SUBMITTED. THE PHOTO SHOWED WHAT APPEARS TO BE THE SLEEVE OF A TROCAR. IN THE PICTURE, A VERTICAL LINE CAN BE OBSERVED BETWEEN THE ROUGH AND THE CLEAR PART OF THE SLEEVE. NO CONCLUSION CAN BE REACH ON WHAT COULD HAVE CAUSED THE REPORTED EVENT. THE BATCH HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED IN GOOD CONDITION AND INSIDE ITS STERILE PACKAGE. THE DEVICE WAS VISUALLY INSPECTED AND A LINE WAS OBSERVED ON THE SLEEVE OF THE DEVICE. INSPECTION UNDER MAGNIFICATION INDICATED THAT THE "LINE" IS OVER THE PARTING LINE OF THE SLEEVE. ALSO, BUBBLES WERE OBSERVED ON THE SURFACE OF THE DEVICE. THE DEVICE WAS FUNCTIONALLY TESTED FOR LEAKS, AND NO ANOMALIES WERE NOTED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE BATCH HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED IN GOOD CONDITION AND INSIDE ITS STERILE PACKAGE. THE DEVICE WAS VISUALLY INSPECTED AND A LINE WAS OBSERVED ON THE SLEEVE OF THE DEVICE. INSPECTION UNDER MAGNIFICATION INDICATED THAT THE "LINE" IS OVER THE PARTING LINE OF THE SLEEVE. ALSO, BUBBLES WERE OBSERVED ON THE SURFACE OF THE DEVICE. THE DEVICE WAS FUNCTIONALLY TESTED FOR LEAKS, AND NO ANOMALIES WERE NOTED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE BATCH HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    THE PRODUCT(S) WAS RECEIVED AND DURING INCOMING/LABELING OPERATION FOUND THE FOLLOWING DEFECT. DETAILS OF THE DEFECT IS CRACKED. NO DEVICE WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37646 ENDOPATH** XCEL* DILATING TIP TROCAR LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA J4A83X

    Patients

    Seq Age Sex Outcome Treatment
    1