BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTBAND SAFEGRIP (LATEX FREE) MULTI-BAND LIGATION KIT

    MDR report key: 9143538 · Received October 1, 2019

    Report

    Report Number
    2951238-2019-01131
    Event Type
    Malfunction
    Date Received
    October 1, 2019
    Date of Event
    June 10, 2019
    Report Date
    October 25, 2019
    Manufacturer
    INTELLIGENT ENDOSCOPY LLC.
    Product Code
    MND
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE OEM PERFORMED AN INVESTIGATION AND PROVIDED THE FOLLOWING RESULTS. THE OEM PERFORMED A DHR REVIEW AND NOTED THAT "THE LOT WAS BUILT TO MANUFACTURING SPECIFICATIONS AND MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT." THE ROOT CAUSE COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR THIS COMPLAINT. THE OEM IS TAKING NO CORRECTIVE ACTIONS AT THIS TIME AS THE FAILURE MODE HAS A LOW OCCURRENCE RANKING. THIS WILL CONTINUE TO BE MONITORED AND TRENDED BY THE OEM.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. WE ARE UNABLE TO DETERMINE A ROOT CAUSE FOR THE REPORTED EVENT AT THIS TIME. IF FURTHER INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BAND FELL OFF AN ESOPHAGEAL VARICE AFTER IT WAS DEPLOYED. THE PATIENT WAS BROUGHT TO THE ENDOSCOPY ROOM WHERE THE PROCEDURES WERE DONE. ANESTHESIA WAS ADMINISTERED AND WELL TOLERATED. THE PATIENT WAS PLACED IN THE LEFT LATERAL DECUBITUS POSITION. INSPECTION OF THE HYPOPHARYNX SHOWED NORMAL VOCAL CORDS WITHOUT REFLUX INJURY OR NEOPLASM. THE VIDEO GASTROSCOPE WAS INTRODUCED INTO THE ESOPHAGUS, STOMACH AND DUODENUM WITH THE FOLLOWING FINDINGS: THE ESOPHAGUS HAD 4 COLUMNS OF MID GRADE VARICES. 6 BANDS WERE DEPLOYED BUT ONE SLIPPED OFF AND A SECOND SET WAS USED TO REPLACE THAT BAND. THE SCOPE WAS SLOWLY WITHDRAWN WHILE SUCTIONING ARE AND FLUID. THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934936 SMARTBAND SAFEGRIP (LATEX FREE) MULTI-BAND LIGATION KIT HEMORRHOIDAL LIGATOR MND INTELLIGENT ENDOSCOPY LLC. SLK-6-LF G11000231

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR