BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLICATOR

    MDR report key: 576102 · Received February 18, 2005

    Report

    Report Number
    1226693-2005-00001
    Event Type
    Injury
    Date Received
    February 18, 2005
    Date of Event
    January 14, 2005
    Report Date
    February 15, 2005
    Manufacturer
    NDO SURGICAL, INC.
    Product Code
    KOG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN CASE PERFORMED, TWO SEPARATE ATTEMPTS WERE MADE TO DEPLOY A PLICATOR IMPLANT IN A PT. BOTH IMPLANT DEPLOYMENT ATTEMPTS WERE UNSUCCESSFUL. SUBSEQUENT TO THE SECOND FAILED IMPLANT DEPLOYMENT ATTEMPT, ENDOSCOPIC EXAMINATION AND SUBSEQUENT ESOPHAGRAM WITH GASTROGRAFIN CONFIRMED A PERFORATION IN THE DISTAL ESOPHAGUS. THE PT UNDERWENT A THORACOTOMY PROCEDURE TO REPAIR A FULL THICKNESS ESOPHAGEAL TEAR ALONG THE RIGHT POSTERIOR LATERAL ASPECT OF THE ESOPHAGUS STARTING NEAR THE ESOPHAGEAL JUNCTION AND EXTENDING PROXIMALLY FOR ABOUT 5 CM. THE SURGICAL REPAIR WAS SUCCESSFUL AND THE PT WAS DISCHARGED FROM THE HOSP FOR REHAB. DURING REHAB, THE PT BECAME ILL, EXPERIENCED A VOMITING EPISODE AND RE-TORE THE REPAIRED ESOPHAGEAL PERFORATION. PT WAS SUBSEQUENTLY READMITTED TO THE HOSP FOR FURTHER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLICATOR ENDOSCOPIC SURGICAL DEVICE KOG NDO SURGICAL, INC. * 04-0903

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| L| R