BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERDIMENSION INREACH SYSTEM

    MDR report key: 2200363 · Received August 11, 2011

    Report

    Report Number
    3004962788-2011-00039
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    June 27, 2011
    Report Date
    August 10, 2011
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(6) 2011 A SITE VISIT WAS PERFORMED. AN ACCURACY TEST AND FUNCTIONAL TEST WERE BOTH PERFORMED AND BOTH PASSED. DURING THE VISIT STAFF MEMBERS WERE INQUIRING ABOUT DIFFERENT BED POSITIONS AND HOW THEY MIGHT AFFECT ACCURACY DURING CASES. THEY NOTED THAT DIFFERENT BED POSITIONS HAD BEEN USED DURING RECENT PROCEDURES. THE SUPERDIMENSION TECHNICAL SPECIALIST EXPLAINED THAT THE BED MUST BE IN THE SAME LOCATION IT WAS MAPPED IN FOR EVERY CASE AND CANNOT BE MOVED. IN ADDITION, HE FURTHER EXPLAINED THAT THIS CAN AFFECT THE ACCURACY OF THE SYSTEM AS DESCRIBED IN THE USER MANUAL. THE SITE HAS PERFORMED TWO SUCCESSFUL CASES SINCE THE SITE VISIT WITH NO ISSUES OR COMPLICATIONS REPORTED. PNEUMOTHORAX IS A KNOWN COMPLICATION WHEN A LUNG BIOPSY IS PERFORMED DURING A TRANSBRONCHIAL LUNG BIOPSY, OR CT-GUIDED PERCUTANEOUS BIOPSY WITH COMPLICATION RATES UP TO APPROXIMATELY 27% WITH THE CT GUIDED PROCEDURE. BIOPSY TOOLS ARE DESIGNED TO HAVE SHARP EDGES AND THEIR FUNCTION IS TO PUNCTURE OR OTHERWISE PENETRATE THE TISSUE IN ORDER TO COLLECT A SPECIMEN. THE USER MANUAL STATES THE FOLLOWING: CAUTION: THERE ARE CERTAIN DETAILS THAT MUST BE VERIFIED BEFORE THE DAILY SETUP IN ORDER TO ASSURE LOCATION ACCURACY. SPECIFICALLY: THE BED ARRANGEMENT (FOR EXAMPLE, THE TABLE-TOP POSITION WITH RESPECT TO SUPPORT LEG AND RAIL POSITION) MUST BE IDENTICAL TO ITS ARRANGEMENT DURING SYSTEM SETUP. THE PROCEDURE ROOM SHOULD BE ARRANGED ACCORDING TO THE PROCEDURE ROOM CONFIGURATION FORM PROVIDED BY THE SUPERDIMENSION TECHNICIAN FOLLOWING THE INSTALLATION OF THE SYSTEM, AND AS APPEARS IN THE PROCEDURE ROOM CONFIGURATION PICTURES.

    Description of Event or Problem · 1

    THE SITE REPORTED THAT THEY HAD A CASE IN (B)(6) THAT HAD RESULTED IN A PNEUMOTHORAX. IT WAS REPORTED THAT ON (B)(6) 2011, THE PHYSICIAN PERFORMED A SUPERDIMENSION CASE UNDER CONSCIOUS SEDATION AND HAD BIOPSIED ON BOTH SIDES OF THE PATIENTS LUNGS. THERE WAS NOTHING NOTABLE FROM THE CASE REPORTED. THE PNEUMOTHORAX WAS IDENTIFIED LATER THAT DAY AND REQUIRED A CHEST TUBE. IT WAS REPORTED THAT THE PATIENT WAS DISCHARGED ON (B)(6) 2011 AND NO FURTHER COMPLICATIONS WERE REPORTED. THE PHYSICIAN INFORMED SUPERDIMENSION OF THE PNEUMOTHORAX AND WAS CONCERNED THE SYSTEM ACCURACY NEEDED TO BE CHECKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERDIMENSION INREACH SYSTEM ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY (ENB) JAK SUPERDIMENSION INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization