BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAPORT RT 5MM REUSE TIT CANN W/GRIP

    MDR report key: 3821196 · Received April 29, 2014

    Report

    Report Number
    1219930-2014-00338
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 14, 2014
    Manufacturer
    COVIDIEN LP, FORMERLY US
    Product Code
    GCJ
    PMA / PMN Number
    K963115
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPIC CHOLEDOCHOLITHOTOMY ACCORDING TO THE REPORTER: THE CUSTOMER STATES, THE DISTAL END OF TROCAR WAS CONSIDERABLY TAPERED. DURING USE WITH THIS ONE, THE BLACK SURFACE PART OF THE FORCEPS GOT PEELED OFF. THEN PEELED PART OF FORCEPS FELL INTO THE CAVITY OF PATIENT. IT DAMAGED THREE OF FORCEPS IN THE SAME WAY. CONFIRMED ANY PIECE OF FORCEPS COULD BE RETRIEVED AND NOTHING LEFT IN THE PATIENT. USING ANOTHER, THE CASE WAS COMPLETED WITH NO PROBLEM. AFTER PROCEDURE WHEN ME INSPECTED THE CONCERNING PRODUCTS THAT WAS USED IN THE CASE AND ALSO THOSE STORED IN THE CUSTOMER, SUCH A TAPERED DEFECTIVE ONE CUT HIS HAND. AS A TOTAL THERE WERE FIVE DEFECTIVE ONES OF THE SAME FAILURE WERE CONFIRMED IN THE CUSTOMER. OPERATING TIME EXTENDED: UNKNOWN. TISSUE DAMAGE: NO. NOTHING FELL INTO THE CAVITY, NO BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256111 VERSAPORT RT 5MM REUSE TIT CANN W/GRIP DISPOSABLE SURGICAL ACCESS DEVICE GCJ COVIDIEN LP, FORMERLY US N3H1908X

    Patients

    Seq Age Sex Outcome Treatment
    1