BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTBAND SAFEGRIP (LATEX FREE) MULTI-BAND LIGATION KIT

    MDR report key: 8462769 · Received March 28, 2019

    Report

    Report Number
    2951238-2019-00580
    Event Type
    Injury
    Date Received
    March 28, 2019
    Date of Event
    December 8, 2018
    Report Date
    November 26, 2019
    Manufacturer
    INTELLIGENT ENDOSCOPY LLC.
    Product Code
    MND
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SMARTBAND WAS DISCARDED BY THE USER FACILITY AFTER THE PROCEDURE. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. AS PART OF INVESTIGATION, THE OEM REVIEWED THE CONTENT OF THIS COMPLAINT AND PROVIDED THE RECOMMENDED THE USER REFERENCE THE SMARTBAND INSTRUCTION MANUAL. AS BLOOD IS A VISCOUS SUBSTANCE AND CAN IMPAIR SUCTION CAPABILITY WITH ACTIVE VARICEAL BLEEDS. THE SMARTBAND SAFEGRIP MULTI- BAND LIGATION KIT INSTRUCTIONS FOR USE STATES UNDER ¿INSTRUCTIONS FOR LIGATION OF VARICES¿, ¿NOTE: IF IRRIGATION IS NEEDED TO CLEAR ENDOSCOPIC VIEW, ATTACH CONNECTOR TUBE TO DEDICATED FLUSH PORT ON LIGATION HANDLE AND INJECT STERILE WATER USING A 60CC SYRINGE¿. THE PHYSICIAN MAY DO THIS AS NEEDED THROUGHOUT THE PROCEDURE TO KEEP THE ENDOSCOPIC VIEW CLEAR AND THE ACCESSORY CHANNEL FREE OF BLOOD. THE OEM PERFORMED A DHR REVIEW AND REPORTED THAT THE LOT WAS BUILT TO MANUFACTURING SPECIFICATIONS AND MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. A REVIEW OF INTELLIGENT ENDOSCOPY¿S COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF THIS OCCURRENCE IS CONSIDERED RARE.

    Description of Event or Problem · 1

    OLYMPUS RECEIVED A MEDWATCH REPORT THAT STATES DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH VARICEAL BANDING, ETHANOLAMINE INJECTION, HEMOSTATIC POWDER SPRAY PROCEDURE, A BAND WAS PLACED ON THE LARGE VARICEAL COLUMN NEAR THE GE JUNCTION BUT THE BAND MISFIRED. THE PATIENT¿S VARICEAL COLUMN WAS SPURTING BLOOD. THE DOCTOR WAS ABLE TO PLACE 3 BANDS ON THE 2 COLUMNS OF VARICES. THE LAST BAND SEEMS TO CONVERT THE ACTIVELY SPURTING BLOOD VARICES TO A SLOWER INTERMITTENT OOZING BLOOD AROUND THE VARICES. THE PATIENT WAS ADMINISTERED 4 CC OF ETHANOLAMINE BY INJECTION AND HEMOSTATIC POWDER WAS SPRAYED ON THE COLUMNS WHICH ONLY STOPPED THE BLEEDING TEMPORARILY. THE SCOPE WAS WITHDRAWN FROM THE PATIENT AND AN EMERGENCY CONSULTATION WAS CONDUCTED WITH INTERVENTIONAL RADIOLOGY (IR). IN ADDITION, THE PATIENT UNDERWENT A POST-OPERATIVE EVALUATION AND WAS DIAGNOSED MODERATE PORTAL HYPERTENSIVE GASTROPATHY. THE PATIENT REMAINED INTUBATED AND RECEIVED 1 UNIT OF BLOOD, ANTIBIOTICS, PROTON PUMP INHIBITORS AND WAS PLACED ON CONTINUED IMAGINING (OCTREOTIDE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255566 SMARTBAND SAFEGRIP (LATEX FREE) MULTI-BAND LIGATION KIT HEMORRHOIDAL LIGATOR MND INTELLIGENT ENDOSCOPY LLC. SLK-6-LF G11000191

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R