BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTBAND SAFEGRIP (LATEX FREE) MULTI-BAND LIGATION PACK

    MDR report key: 8498071 · Received April 9, 2019

    Report

    Report Number
    2951238-2019-00718
    Event Type
    Malfunction
    Date Received
    April 9, 2019
    Date of Event
    March 14, 2019
    Report Date
    October 31, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION RECEIVED FROM THE ORIGINAL EQUIPMENT MANUFACTURER (OEM). PLEASE SEE THE UPDATES IN SECTIONS: G4, G7, H2 AND H10. ADDITIONAL INFORMATION WAS RECEIVED FROM THE ORIGINAL EQUIPMENT MANUFACTURER STATES THAT A POTENTIAL ROOT CAUSE FOR THE BAND¿S IMPROPER DEPLOYMENT CAN BE RELATED TO AIR ESCAPING AROUND THE SMARTBAND HANDLE STEM, SINCE A BIOPSY CAP WAS NOT PLACED ON THE ACCESSORY CHANNEL AT THE BEGINNING OF THE PROCEDURE. THE SMARTBAND SAFE GRIP INSTRUCTIONS FOR USE STATES HOW TO INSERT THE HANDLE INTO THE BIOPSY CAP OF THE GASTROSCOPE. ¿MAINTAINING A TIGHT SEAL IS CRITICAL TO PLACING THE BAND CORRECTLY ONTO THE VARIX. IF THE GASTROSCOPE DOES NOT HAVE PROPER SUCTION, THE TISSUE CAN SLIP OUT OF THE CAP AND THE BAND WILL NOT BE APPLIED CORRECTLY.¿ AS PART OUR INVESTIGATION, AN OLYMPUS LOCAL SALES REP AND CLINICAL EDUCATION SPECIALIST RETRAINED THE STAFF ON HOW TO USE THE SMARTBAND SAFE GRIP PRODUCTS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE SMARTBAND SAFEGRIP MULTI-BAND LIGATION KIT (SLK-6- LF), LOT NUMBER: G11000207 AND THE SMARTBAND SAFEGRIP MULTI-BAND LIGATION PACK LOT NUMBERS: G11000192 AND G11000193. ALL LOTS WERE BUILT TO MANUFACTURING SPECIFICATIONS AND MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. IN ADDITION, A REVIEW OF INTELLIGENT ENDOSCOPY'S COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF THE OCCURRENCE IS CONSIDERED RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED; HOWEVER, BASED ON SIMILAR REPORTS, THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) REPORTED THAT A POTENTIAL CONTRIBUTING FACTOR IS TOO MUCH TENSION APPLIED ON THE DEPLOYMENT CORD. THE OEM ALSO, REPORTED THAT AN OVER ROTATING OF THE HANDLE DURING BAND DEPLOYMENT CAN CAUSE THIS TYPE OF TENSION. THE INSTRUCTIONS FOR USE UNDER "SYSTEM PREPARATION" STATES ¿DURING DEVICE SETUP, PUTTING TOO MUCH TENSION ON THE DEPLOYMENT CORD CAN CAUSE PREMATURE BAND DEPLOYMENT.¿ IN ADDITION, THE OEM REPORTED THAT THE POSSIBILITY OF A BAND FALLING OFF INTO A PATIENT IS CONSIDERED RARE.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THREE OF THE SMART BAND FELL INTO THE PATIENT AFTER BEING FIRED. IT WAS REPORTED THAT THE BANDS HAD BEEN DEPLOYING TWO AT A TIME AND FALLING OFF OF THE VARICES. THE STAFF REALIZED THAT THE BAND AND SCOPE SET UP WAS WRONG. THE BIOPSY CAP WAS REMOVED AND THE DEVICE¿S HANDLE WAS PLACED DIRECTLY INTO THE SCOPE. THE ATTENDING DOCTOR OVER THE PROCEDURE AND PLACED THREE MORE BANDS. THE SCOPE WAS WITHDRAWN TO COMPLETE THE PROCEDURE THE BANDS THAT HAD FALLEN OFF WERE LEFT IN THE PATIENT TO PASS NATURALLY. THERE WAS NO PATIENT INJURY REPORTED. THIS IS REPORT 1 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290219 SMARTBAND SAFEGRIP (LATEX FREE) MULTI-BAND LIGATION PACK HEMORRHOIDAL LIGATOR MND INTELLIGENT ENDOSCOPY LLC. SLP-6-LF G11000192

    Patients

    Seq Age Sex Outcome Treatment
    1 SLK-6-LF/LOT# G11000207| SLP-6-LF/ LOT#G11000193