BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLICATOR

    MDR report key: 666235 · Received January 7, 2006

    Report

    Report Number
    1226693-2006-00001
    Event Type
    Injury
    Date Received
    January 7, 2006
    Report Date
    January 6, 2006
    Manufacturer
    NDO SURGICAL, INC.
    Product Code
    KOG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NDO SURGICAL WAS INFORMED IN 2005 THAT DR MAY HAVE HAD A PT WITH AN ADVERSE EVENT FOLLOWING A PLICATOR PROCEDURE. ATTEMPTS TO GAIN FURTHER INFO WERE INITIATED. THE NEXT DAY, DR PROVIDED NDO SURGICAL WITH THE FOLLOWING INFO. FEMALE PT WITH GERD HAD THE NDO PLICATOR PROCEDURE IN 2005. THE PROCEDURE WAS DONE UNDER PROPOFOL SEDATION WITH AN ANETHESIOLOGIST IN ATTENDANCE. PROPHYLACTIC ZOFRAN WAS ADMINISTERED DURING THE PROCEDURE. THE PROCEDURE WENT VERY EASILY AND AN ENDOPLICATION SUTURE WAS PLACED IN THE FUNDUS BELOW THE ESOPHAGOGASTRIC FOLD. THE PT AWAKENED WITH A MIDEPIGASTRIC PAIN AND A LEFT CHEST PAIN THAT WAS SEVERE REQUIRING HIGH DOSES OF DILAUDID. SHE WAS ADMITTED TO THE HOSP AND A CHEST CT WAS PERFORMED. THIS SHOWED A SMALL PNEUMOTHORAX (<10%) AND SMALL PNEUMOPERITONEUM. THE PT WAS TREATED WITH IV AND ORAL ANTIBIOTICS. THE PNEUMOTHORAX DECREASED OVER THE NEXT 48 HOURS AND THE PT WAS DISCHARGED. NEITHER EVENT WAS CONSIDERED LIFE THREATENING. THE PT FOLLOWED UP WITH HER LOCAL PHYSICIAN. SHE CONTINUED TO HAVE PAIN AND WAS SUBSEQUENTLY FOUND TO HAVE LEFT LOWER LOBE PNEUMONIA. THE PNEUMONIA ONSET WAS REPORTED TO BE APPROX 14 DAYS POST PROCEDURE. THE REPORTING PHYSICIAN DID NOT FEEL THAT THE PNEUMONIA WAS CHEMICALLY INDUCED, BUT HYPOTHESIZED THAT IT MAY HAVE BEEN BROUGHT ON DUE TO POOR INSPIRATION DUE TO PAIN. THIS EVENT WAS ALSO TREATED WITH ANTIBIOTICS. IN DECEMBER, 2005 THE PT REPORTED LESS CHEST AND ABDOMINAL PAIN. SHE WAS HAVING NO REFLUX SYMPTOMS. NO PRODUCT MALFUNCTION WAS REPORTED TO HAVE OCCURRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization