BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIFISH

    MDR report key: 468669 · Received June 19, 2003

    Report

    Report Number
    468669
    Event Type
    Injury
    Date Received
    June 19, 2003
    Date of Event
    June 4, 2003
    Report Date
    June 18, 2003
    Manufacturer
    GREER MEDICAL, INC.
    Product Code
    GCZ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGIFISH WAS USED IN A SURGICAL PROCEDURE PERFORMED ON A BARIATRIC CASE (GASTRIC STAPLING). THE SURGIFISH IS A SUPPLY (PIECE OF RUBBER) THAT IS USED BETWEEN THE VISCERA AND AN ORGAN/VESSEL. THE SURGIFISH IS YELLOW IN COLOR AND DID NOT HAVE AN ATTACHED STRING AND RING TO ASSIST WITH ITEM LOCATION IN THE ABDOMINAL CAVITY. THE ITEM WAS LEFT IN THE PT. BECAUSE IT IS NOT RADIOPAQUE, IT DOES NOT SHOW UP ON X-RAY. IT WAS DISCOVERED THREE MONTHS LATER IN AN UNRELATED SURGERY AT ANOTHER HOSPITAL. THE ITEM PERFORATED THE BOWEL IN TWO AREAS. THE PT HAD SEVERAL HOSP ADMISSIONS COMPLAINING OF ABDOMINAL PAIN AND NAUSEA PRIOR TO THE DETECTION OF THE FOREIGN BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGIFISH VISCERA RETAINER GCZ GREER MEDICAL, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R