BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAPORT¿ BLADELESS OPTICAL TROCAR WITH FIXATION CANNULA 12MM SHORT

    MDR report key: 6036471 · Received October 18, 2016

    Report

    Report Number
    9612501-2016-00798
    Event Type
    Malfunction
    Date Received
    October 18, 2016
    Date of Event
    September 17, 2016
    Report Date
    September 20, 2016
    Manufacturer
    COVIDIEN
    Product Code
    GCJ
    PMA / PMN Number
    K130435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO FURTHER DETAILS REGARDING PATIENT, PRODUCT OR PROCEDURE WERE PROVIDED BY THE REPORTER. (B)(4) - ISSUE ASSOCIATED WITH COMPRISING MATERIAL(S) BEING PULLED APART OR INTO PIECES BY FORCE, WRENCHING, OR LACERATION.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER; AFTER ABOUT 20MIN OF USE DURING A LAPAROSCOPIC APPENDECTOMY, THE SEAL SEEMED TO BE BROKEN AND AIR LEAKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MIN. THERE WAS NO TISSUE DAMAGE. THE INCISION SITE WAS NOT EXTENDED. NOTHING FELL INTO THE PATIENT'S CAVITY. NO BLEEDING OCCURRED. THE PATIENT GENDER IS NOT AVAILABLE. THE PATIENT AGE IS NOT AVAILABLE. THE PATIENT WEIGHT IS NOT AVAILABLE. THE DEVICE WAS NOT REPROCESSED/RE-STERILIZED PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688219 VERSAPORT¿ BLADELESS OPTICAL TROCAR WITH FIXATION CANNULA 12MM SHORT LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ COVIDIEN ONB12SHF J6D2800X

    Patients

    Seq Age Sex Outcome Treatment
    1