BEUDAMED
    FDA Adverse Event Summary report: N

    CRANIAL NAVIGATION SOFTWARE (VERSION 2.1.1)

    MDR report key: 4182091 · Received October 14, 2014

    Report

    Report Number
    8043933-2014-00035
    Date Received
    October 14, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 11, 2014
    Manufacturer
    BRAINLAB AG
    Product Code
    HAW
    PMA / PMN Number
    K092467
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A RISK TO THE PATIENT'S HEALTH COULD NOT BE EXCLUDED FOR THESE SPECIFIC CIRCUMSTANCES, SINCE INADVERTENTLY HEALTHY BRAIN TISSUE WAS DISSECTED INSTEAD OF THE INTENDED TUMOR TISSUE, ALTHOUGH: THERE IS NO INDICATION OF A SYSTEMATIC ERROR OR MALFUNCTION OF THE BRAINLAB DEVICE, THE CORRESPONDING MEASURES TO MINIMIZE THIS ANTICIPATED RISK AS LOW AS REASONABLY PRACTICABLE ARE ALREADY IN PLACE, ACCORDING TO THE SURGEON THE DESCRIBED SYMPTOMS ARE LIKELY TO FADE OVER TIME AND ARE NOT NECESSARILY RELATED TO THE DESCRIBED ISSUE WITH THE BRAINLAB DEVICE. DESPITE A COMPREHENSIVE INVESTIGATION HAS BEEN PERFORMED, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THIS SPECIFIC ISSUE. ACCORDING TO THE RESULTS OF THE BRAINLAB INVESTIGATION AND THE INFORMATION PROVIDED BY THE HOSPITAL, IT CAN BE CONCLUDED THAT THE DISCREPANCY OF THE INFORMATION PROVIDED BY THE BRAINLAB NAVIGATION AND THE PATIENT ANATOMY WAS CAUSED BY A BRAIN SHIFT (WHICH WOULD LEAD TO SHIFT BETWEEN THE VIRTUAL DISPLAY OF THE PATIENT IMAGE DATA SETS AND THE ACTUAL PATIENT ANATOMY. APPARENTLY THE POTENTIAL DISCREPANCY WAS ALSO NOT DETECTED WITH THE REQUIRED ACCURACY VERIFICATION BY THE USER WITH THE FUNCTIONS AVAILABLE IN THE BRAINLAB NAVIGATION. BRAINLAB INTENDS TO -INFORM THIS HOSPITAL ABOUT THE POTENTIAL EFFECTS OF BRAIN SHIFT AND OFFER TO THE USERS AT THIS HOSPITAL TO REITERATE THE REQUIRED ACCURACY VERIFICATION. THERE IS NO INDICATION OF A SYSTEMATIC ERROR OR MALFUNCTION OF THE BRAINLAB NAVIGATION DEVICE. BRAINLAB MEASURES TO MINIMIZE THIS ANTICIPATED RISK AS LOW AS REASONABLY PRACTICABLE ARE ALREADY IN PLACE.

    Description of Event or Problem · 1

    AN OPEN CRANIOTOMY TO REMOVE A 1.5CM LESION IN THE MOTOR CORTEX WAS PLANNED TO BE PERFORMED WITH THE AID OF THE BRAINLAB CRANIAL NAVIGATION SYSTEM. DURING THE PROCEDURE THE SURGEON: PERFORMED INITIAL REGISTRATION OF THE PATIENT (MATCHING OF VIRTUAL DISPLAY OF PATIENT IMAGE DATA AND ACTUAL PATIENT ANATOMY) WITH STATISTICALLY MEDIUM PRECISION. COULD NOT LOCATE THE TUMOR IN THE POSITION SHOWN BY THE NAVIGATION SYSTEM. USED ULTRASOUND TO VERIFY THAT THE NAVIGATION SYSTEM DOES NOT MATCH THE PATIENT ANATOMY. REPEATED THE REGISTRATION OF THE PATIENT WITH STATISTICALLY GOOD PRECISION. AGAIN COULD NOT LOCATE THE TUMOR IN THE NEW POSITION SHOWN BY THE NAVIGATION SYSTEM. DECIDED TO ABANDON NAVIGATION AND COMPLETED THE SURGERY. HISTOLOGY OF THE DISSECTED TISSUE HAS NOT YIELDED A DIAGNOSIS. ACCORDING TO THE HOSPITAL (SURGEON) THE PATIENT SUFFERED FROM WEAKNESS IN THE FACE AND ARM, WHICH IS A GENERAL RISK FOR SURGERY IN THE MOTOR CORTEX REGION AND NOT SPECIFICALLY LINKED TO THE DESCRIBED ISSUE. TO THIS DATE THE PATIENT'S FACE AND SPEECH IS IMPROVING, THE WEAKNESS IN THE ARM STILL SIGNIFICANT. THE SYMPTOMS ARE LIKELY TO FADE OVER TIME. THERE ARE NO REMEDIAL ACTIONS NECESSARY. THE PATIENT WILL RECEIVE WHOLE BRAIN RADIOTHERAPY AS WE PLANNED BEFORE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649001 CRANIAL NAVIGATION SOFTWARE (VERSION 2.1.1) IMAGE GUIDED SURGERY SYSTEM/STEREOT. HAW BRAINLAB AG 22214C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other