BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRIGHTMATTER GUIDE

    MDR report key: 6584291 · Received May 23, 2017

    Report

    Report Number
    3012075008-2017-00001
    Event Type
    Injury
    Date Received
    May 23, 2017
    Date of Event
    April 1, 2017
    Report Date
    May 19, 2017
    Manufacturer
    SYNAPTIVE MEDICAL INC.
    Product Code
    HAW
    UDI-DI
    00670082000078
    PMA / PMN Number
    K153281
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE WORKFLOW FILES, LOGS, AND PATIENT SCANS FOR SURGERIES ON (B)(6) 2017 WERE OBTAINED AND ANONYMIZED ON (B)(6) 2017. THE DATA WERE ANALYZED BY A SYNAPTIVE SOFTWARE DEVELOPER. IN ADDITION, A SYNAPTIVE REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. THE HARDWARE, SOFTWARE AND INSTRUMENTS ALL PASSED SPECIFICATIONS. THE ROOT CAUSE IS THAT INADEQUATE REGISTRATION WAS PERFORMED BY THE CLINICAL STAFF DURING THE PROCEDURE (AGAINST EXISTING SYNAPTIVE DOCUMENTATION AND SOFTWARE CONTROLS). THE SURGEON ALSO INDICATED THAT HE WAS SATISFIED WITH THE OUTCOME OF THE SECOND PROCEDURE COMPLETED USING THE SAME SYSTEM.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT DURING THE PROCEDURE BRIGHTMATTER GUIDE HAD LED THE SURGEON TO BELIEVE THAT HE WAS AT THE SITE OF THE TUMOR, SO HE PROCEEDED WITH RESECTION. HOWEVER, POST-OPERATIVE PATHOLOGY RESULTS INDICATED THAT THE TISSUE WAS HEALTHY BRAIN TISSUE. A SECOND PROCEDURE WAS THEN SCHEDULED FOR THE PATIENT. POST-OPERATIVE PATHOLOGY RESULTS INDICATED THAT THE TISSUE WAS GRADE 1 MENINGIOMA. DURING BOTH PROCEDURES, ANATOMICAL LANDMARKS WERE USED FOR REGISTRATION USING THE SAME SYSTEM. NO PATIENT HARM, OR DEATH WAS OBSERVED DURING THE PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366279 BRIGHTMATTER GUIDE SURGICAL NAVIGATION SYSTEM HAW SYNAPTIVE MEDICAL INC. 1.3.1 N/A 00670082000078

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention