BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTBAND SAFEGRIP (LATEX FREE) MULTI-BAND LIGATION KIT

    MDR report key: 8628027 · Received May 21, 2019

    Report

    Report Number
    2951238-2019-00855
    Event Type
    Malfunction
    Date Received
    May 21, 2019
    Date of Event
    April 3, 2019
    Report Date
    January 28, 2020
    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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS CONDUCTED BY THE OEM FOR THE CONCERNED DEVICE. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE A SUMMARY OF THE INVESTIGATION RESULTS. FOUR COMPONENTS OF THE DEVICE WERE RETURNED AND THEN DECONTAMINATED. THE DIMENSIONS OF THE HANDLE, LOADING DEVICE, BARREL AND THE DEPLOYMENT CORD WERE WITHIN SPECIFICATION. THERE WERE NO BANDS TO ASSESS AS NO BANDS WERE RETURNED; THEREFORE, NO DEFINITIVE ROOT CAUSE FOR THE MISFIRE COULD BE DETERMINED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR LOT G11000220 AND THE LOT WAS BUILT TO MANUFACTURING SPECIFICATIONS AND MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. THE OEM RECOMMENDS TO CONTINUE WITH CUSTOMER TRAINING/SUPPORT ON PROPER USE OF THE DEVICE. INCLUDING THE REVIEW OF THE INSTRUCTIONS FOR USE THAT SPECIFICALLY STATES, "USE OF AN ENDOSCOPE IN A SOUND STATE OF REPAIR IS A PREREQUISITE FOR A SUCCESSFUL MULTI-BAND LIGATION PROCEDURE."

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2019, THE MANUFACTURER RECEIVED A COPY OF A MEDSUN REPORT FROM THE USER FACILITY. BASED ON THE MEDSUN REPORT, A SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION AND TO UPDATE SECTIONS B3, D4. ADDITIONALLY, A DEVICE HISTORY RECORD REVIEW (H6) WAS PERFORMED. THE LOT WAS BUILT TO MANUFACTURING SPECIFICATIONS AND MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT.

    Additional Manufacturer Narrative · 1

    THE USER FACILITY FURTHER REPORTED THAT PRIOR TO DEPLOYMENT, THE SECOND AND THIRD PORTION OF THE PATIENT'S DUODENUM WERE NORMAL. THE DUODENAL BULB WAS NORMAL. THE PYLORUS WAS PATENT. THE STOMACH ANTRUM HAD MINI MAL VASCULAR STASIS COMPATIBLE WITH EARLY GASTRIC ANTRAL VASCULAR ECTASIA (GAVE). RETROFLEXED VIEW SHOWS NO OTHER ABNORMALITY. THE VARICES WERE NOT SEEN. THE SQUAMOCOLUMNAR JUNCTION WAS AT APPROXIMATELY 39 CM WITH A -3 CM HIATAL HERNIA. THE ESOPHAGUS WAS COMPLETELY NORMAL, EXCEPT FOR 3 COLUMNS OF MID GRADE VARICES. THE SCOPE WAS SLOWLY WITHDRAWN WHILE SUCTIONING AIR AND FLUID. THE PATIENT TOLERATED THE PROCEDURE WELL. IT IS UNKNOWN IF THE BAND FELL INTO THE PATIENT OR IF IT WAS RETRIEVED. THERE WAS NO UNEXPECTED BLEEDING OR PATIENT HARM. THERE WAS NO DELAY IN THE PROCEDURE. THE REFERENCED DEVICE IS NOT EXPECTED TO BE RETURNED. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED; HOWEVER, BASED ON SIMILAR INVESTIGATIONS BY THE ORIGINAL EQUIPMENT MANUFACTURER (OEM), A POTENTIAL CONTRIBUTING FACTOR IS TOO MUCH TENSION APPLIED ON THE DEPLOYMENT CORD. ALSO, OVER ROTATING OF THE HANDLE DURING BAND DEPLOYMENT CAN CAUSE THIS TYPE OF TENSION. THE DEVICE INSTRUCTIONS FOR USE MANUAL UNDER "SYSTEM PREPARATION" STATES, "DURING DEVICE SETUP, PUTTING TOO MUCH TENSION ON THE DEPLOYMENT CORD CAN CAUSE PREMATURE BAND DEPLOYMENT."

    Description of Event or Problem · 1

    ON APRIL 23, 2019, THE MANUFACTURER RECEIVED A MEDWATCH REPORT (# (B)(4)) WHICH STATES, IN (B)(6) 2019, DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE WITH BANDING OF ESOPHAGEAL VARICES PROCEDURE FOUR BANDS WERE DEPLOYED AND ONE MISFIRED. THE INTENDED PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422584 SMARTBAND SAFEGRIP (LATEX FREE) MULTI-BAND LIGATION KIT HEMORRHOIDAL LIGATOR MND INTELLIGENT ENDOSCOPY LLC. SLK-6-LF G11000220

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR