BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE¿ BLUNT TIP TROCAR 10MM

    MDR report key: 6068132 · Received October 31, 2016

    Report

    Report Number
    2647580-2016-00894
    Event Type
    Malfunction
    Date Received
    October 31, 2016
    Date of Event
    September 30, 2016
    Report Date
    October 3, 2016
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    GCJ
    PMA / PMN Number
    K924011
    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.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER; DURING A TOTALLY EXTRAPERITONEAL PROCEDURE, THE BALLOON WOULD NOT INFLATE COMPLETELY. THE DEVICE WAS NOT USED FOR PATIENT AND THERE WAS NO PROBLEM ASSOCIATED WITH THE PATIENT. ADDITIONAL TISSUE RESECTION WAS NOT REQUIRED. THERE WAS NO TISSUE DAMAGE. THE INCISION SITE WAS NOT EXTENDED. NOTHING FELL INTO THE PATIENT'S CAVITY. THE PRODUCT DID NOT LOCK ON TISSUE AND WAS REMOVED FROM THE TISSUE WITHOUT DAMAGING IT. NO BLEEDING OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE SURGICAL TIME WAS NOT EXTENDED. 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
    718155 AUTO SUTURE¿ BLUNT TIP TROCAR 10MM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ COVIDIEN, FORMERLY USSC PUERTO RICO INC OMST10BT

    Patients

    Seq Age Sex Outcome Treatment
    1