BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH DILATING TIP OBTUTR

    MDR report key: 1782123 · Received February 12, 2008

    Report

    Report Number
    1527736-2008-00826
    Event Type
    Malfunction
    Date Received
    February 12, 2008
    Report Date
    January 18, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    GCJ
    PMA / PMN Number
    K971738
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE TROCAR BROKE OFF AND FELL INTO THE PT. IT WAS RETRIEVED. THEY COMPLETED THE PROCEDURE WITH A NEW TROCAR. NO PT CONSEQUENCE REPORTED. NO OTHER DETAILS ARE KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH DILATING TIP OBTUTR GCJ ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1