BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 10MM

    MDR report key: 3982499 · Received June 23, 2014

    Report

    Report Number
    2647580-2014-00472
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 28, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO, INC.
    Product Code
    GCJ
    PMA / PMN Number
    K924011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: CHOLECYSTECTOMY. ACCORDING TO THE REPORTER: BEFORE APPLYING THE BLUNT TIP TROCAR 10MM (OMS-T10BT) ON THE PATIENT, A SCRUB NURSE TRIED TO CHECK BALLOONING OF THE TROCAR, USING A SYRINGE. HOWEVER, BALLOONING DID NOT WORK AT ALL, EVEN THOUGH THE AIR WENT THROUGH THE "INFLATION BULB" COMPLETELY FROM THE SYRINGE. LEAKAGE SOUND COULD BE HEARD FROM SOMEWHERE AROUND THE INFLATION BULB. AS A RESULT, THE SCRUB NURSE REPLACED THE BROKEN TROCAR WITH NEW OMS-T10BT. THE INFORMATION ABOUT THE PATIENT WAS NOT GIVEN. THERE WAS NO PATIENT INJURY. THERE WAS NOT ANY REINFORCEMENT MATERIAL USED IN CONJUNCTION WITH THE STAPLING DEVICE. THE SURGICAL TIME WAS NOT EXTENDED BY MORE THAN 30 MINUTES DUE TO THE PRODUCT PROBLEM. THE SUBJECT DEVICE WILL BE RETURNED FOR INVESTIGATION. THERE WAS NO UNANTICIPATED TISSUE LOSS AS A RESULT OF THIS PROBLEM .THERE WAS NO TISSUE DAMAGE AS A RESULT OF THIS PROBLEM. THERE WAS NO BLOOD LOSS OF 500CC OR MORE DUE TO THE PRODUCT PROBLEM .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367153 SPACEMAKER BLUNT TIP TROCAR 10MM SPACEMAKER BALLOON GCJ COVIDIEN, FORMERLY USSC PUERTO RICO, INC. P2L0529X

    Patients

    Seq Age Sex Outcome Treatment
    1