BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLICATOR

    MDR report key: 2948049 · Received November 30, 2007

    Report

    Report Number
    1226693-2007-00006
    Event Type
    Injury
    Date Received
    November 30, 2007
    Date of Event
    October 7, 2007
    Report Date
    November 30, 2007
    Manufacturer
    NDO SURGICAL, INC.
    Product Code
    KOG
    PMA / PMN Number
    K032820
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS: THERE IS NO OBVIOUS PRODUCT MISUSE AND NO PRODUCT MALFUNCTION REPORTED IN THIS CASE. IT IS UNCLEAR WHETHER THE PRE-PROCEDURE HIGH LEVEL DISINFECTION PROTOCOL USED BY THE SITE CONTRIBUTED TO THE PATIENT'S INFECTION. HOWEVER, THE TIMING OF EVENT ONSET AND THE "OBSERVATION" THAT PLICATOR NEEDLES PENETRATED THE PATIENT'S DIAPHRAGM AND PLEURA STRONGLY IMPLICATES THE PLICATOR TREATMENT AS A CAUSAL AGENT IN THIS INCIDENT.

    Description of Event or Problem · 1

    PATIENT DEVELOPED EMPYEMA IN THE LEFT PLEURA 2 DAYS POST-PLICATOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLICATOR ENDOSCOPE / ACCESSORY KOG NDO SURGICAL, INC. 160-01130 07-0005

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R