BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTBAND SAFEGRIP (LATEX FREE) MULTI-BAND LIGATION KIT

    MDR report key: 9145107 · Received October 2, 2019

    Report

    Report Number
    2951238-2019-01132
    Event Type
    Malfunction
    Date Received
    October 2, 2019
    Date of Event
    July 31, 2019
    Report Date
    October 11, 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 WAS DISCARDED; THEREFORE AN EVALUATION IS NOT POSSIBLE AND A ROOT CAUSE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PERFORMING AN EGD (ESOPHAGOGASTRODUODENOSCOPY) ON A PATIENT, TREATMENT FOR ESOPHAGEAL VARICES WAS NECESSARY. UPON USE OF THE SMART BAND LIGATION KIT MADE BY INTELLIGENT ENDOSCOPY, THE INITIAL BAND PLACEMENT FUNCTIONED CORRECTLY. A SECOND BAND WAS PLACED WITH PROPER SUCTION; HOWEVER, THE BAND POPPED OFF OF THE VARICES. PER OPERATIVE NOTES, THE BAND WAS NOT REPLACED. THIS OCCURRENCE HAD THE POTENTIAL TO CAUSE A MASSIVE GI BLEED IF THE OCCURRENCE WAS NOT NOTICED IMMEDIATELY. THERE WAS LESS THAN 5ML OF BLOOD LOSS. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    938089 SMARTBAND SAFEGRIP (LATEX FREE) MULTI-BAND LIGATION KIT HEMORRHOIDAL LIGATOR MND INTELLIGENT ENDOSCOPY LLC. SLK-6-LF G11000248

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR