BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEALING UNIT FROM 5MM TROCARS

    MDR report key: 4862171 · Received June 17, 2015

    Report

    Report Number
    2916714-2015-00508
    Event Type
    Malfunction
    Date Received
    June 17, 2015
    Report Date
    June 17, 2015
    Manufacturer
    AESCULAP AG & CO KG
    Product Code
    GCJ
    PMA / PMN Number
    K101937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    U.S. REPORTING AGENT NOTIFIED ON: (B)(6) 2015. MFG SITE INVESTIGATION: RECEIVED SEAL UNITS SHOW CRACKS. ROOT CAUSE IS DAMAGE BY SHARP OBJECT; USER RELATED. THERE PRODUCTS ARE TESTED AT 100% REGARDING THEIR INTACTNESS BEFORE THEY ARE SENT TO STOCK. THEREFORE A FAILURE IN MFG IS EXCLUDED. THERE ARE NO INDICATIONS OF PRODUCT OR MATERIAL DEVIATIONS. REPORTED DEVICE IS AN ACCESSORY PART FOR REUSABLE TROCAR SYSTEM. TROCAR SYSTEM PROCODE IS (B)(4). (K):K101937.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). TEAR ON VALVE BELOW THE TROCAR. OPERATION TIME WAS EXTENDED DUE TO NECESSARY REPLACEMENT OF DEVICE DUE TO LEAKAGE OF THE SEAL. MEDWATCH 2916714-2015-00507 AND 2916714-2015-00492 ARE FROM THE SAME EVENT AS THIS ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392633 SEALING UNIT FROM 5MM TROCARS TROCAR ACCESSORIES GCJ AESCULAP AG & CO KG EK080P

    Patients

    Seq Age Sex Outcome Treatment
    1 Other