BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL* BLADELESS TROCAR

    MDR report key: 3123682 · Received May 22, 2013

    Report

    Report Number
    3005075853-2013-02482
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 18, 2013
    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). UPON VISUAL INSPECTION OF THE PACKAGE, IT WAS CONFIRMED THAT A HAIR WAS PRESENT IN THE PACKAGE AND THAT THE HAIR EXTENDS ACROSS THE WIDTH OF THE SEAL. THE OTHER FIVE PACKAGES IN THE SALES UNIT HAD NO DEFECTS. LOT HISTORY RECORDS FOR K4C96P WERE REVIEWED. NO PROTOCOLS, DEFECTS, NON-CONFORMANCES OR QUARANTINE NOTED. THE PRODUCT MET ALL IN-PROCESS AND FINISHED GOODS SPECIFICATIONS UPON RELEASE OF THE PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRODUCT(S) RECEIVED DURING INCOMING/LABELING OPERATION FOUND THE FOLLOWING DEFECT. DETAILS OF THE DEFECT IS ORGANIC PARTICLE MATTER INSIDE POUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226090 ENDOPATH** XCEL* BLADELESS TROCAR LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA K4C96P

    Patients

    Seq Age Sex Outcome Treatment
    1