BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTBAND SAFEGRIP MULTI-BAND LIGATION KIT

    MDR report key: 8577305 · Received May 3, 2019

    Report

    Report Number
    8577305
    Event Type
    Malfunction
    Date Received
    May 3, 2019
    Date of Event
    April 8, 2019
    Report Date
    April 16, 2019
    Manufacturer
    INTELLIGENT ENDOSCOPY LLC (OLYMPUS)
    Product Code
    FHN
    UDI-DI
    00850261006033
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    BANDER MALFUNCTION. BANDER MISFIRED ON THE WAY OUT OF ESOPHAGUS ON ITS OWN. PROCEDURAL NOTE: PATIENT WHO PRESENTS TO ENDOSCOPY FOR EGD TO EVALUATE VARICES LAST BANDED EARLIER THIS YEAR. PROCEDURE PERFORMED: HB ESOPHAGOGASTRODUODENOSCOPY WITH VARICEAL BAND LIGATION. THE VIDEO GASTROSCOPE WAS INTRODUCED INTO THE ESOPHAGUS, STOMACH, AND DUODENUM WITH THE FOLLOWING FINDINGS: THE SECOND AND THIRD PORTION OF THE DUODENUM WERE NORMAL AND THE PAPILLA OF VATER WAS SEEN. DUODENAL BULB WAS NORMAL. THE PYLORUS WAS PATENT. STOMACH HAD COBBLESTONING OF THE MUCOSA. RETROFLEXED VIEW SHOWS NO OTHER ABNORMALITY. THE SQUAMOCOLUMNAR JUNCTION WAS AT APPROXIMATELY 38 CM WITH A NODULAR INFLAMED AREA, LIKELY PREVIOUS BANDING. THE ESOPHAGUS HAD SCARS AND ULCERS FROM PREVIOUS BANDING A 2 COLUMNS OF VARICES THAT WERE BANDED X4. ONE BAND WENT INTO THE EGJ AREA. THE SCOPE WAS SLOWLY WITHDRAWN WHILE SUCTIONING AIR AND FLUID. THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369947 SMARTBAND SAFEGRIP MULTI-BAND LIGATION KIT LIGATOR, HEMORRHOIDAL FHN INTELLIGENT ENDOSCOPY LLC (OLYMPUS) SLK-6-LF G11000214 00850261006033

    Patients

    Seq Age Sex Outcome Treatment
    1 18250 DA