BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORIGIN DATA MANAGEMENT (VERSION 3.2, SOFTWARE COMPONENT)

    MDR report key: 24827620 · Received April 9, 2026

    Report

    Report Number
    8043933-2026-00021
    Event Type
    Malfunction
    Date Received
    April 9, 2026
    Date of Event
    March 12, 2026
    Report Date
    April 24, 2026
    Manufacturer
    BRAINLAB SE
    Product Code
    QIH
    PMA / PMN Number
    K243698
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B2, H1: A RISK TO PATIENT HEALTH COULD NOT BE EXCLUDED FOR THESE SPECIFIC CIRCUMSTANCES. IF THE INCORRECT MERGING OF DATA FROM TWO UNRELATED PATIENT RECORDS IS NOT DETECTED BY THE USER IN THE SUBSEQUENT STEPS OF TREATMENT PREPARATION, AND DATA FROM PATIENT_A IS USED TO MAKE CLINICAL DECISIONS FOR PATIENT_B, THIS COULD, IN A WORST-CASE SCENARIO RESULT IN TREATMENT ERROR OR SERIOUS INJURY. ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE ISSUE WAS DETECTED BEFORE THE LOCALIZATION AND ANY SURGICAL PROCEDURE WAS PERFORMED ON THE PATIENT. THERE WAS NO NEGATIVE CLINICAL EFFECT ON THE PATIENT DUE TO THE INCORRECT MERGE OF PATIENT RECORDS, ALSO NOT DUE TO SURGERY/ANESTHESIA PROLONGATION OF CA. 30 MINUTES. THE FINAL OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED. A COMPREHENSIVE INVESTIGATION BY BRAINLAB REGARDING THIS SPECIFIC INCIDENT IS CURRENTLY ONGOING AND FINAL CONCLUSIONS ARE PENDING. BRAINLAB PLANS TO ISSUE A FOLLOW-UP REPORT UPON COMPLETION OF THE INVESTIGATION. H6, H7: A COMPREHENSIVE INVESTIGATION BY BRAINLAB REGARDING THIS SPECIFIC INCIDENT IS CURRENTLY ONGOING AND FINAL CONCLUSIONS ARE PENDING. BRAINLAB PLANS TO ISSUE A FOLLOW-UP REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    A PATIENT RECORD REQUIRED FOR STEREOTACTIC PLANNING COULD NOT BE FOUND DURING A FRAME-BASED STEREOTACTIC BIOPSY FOR A SUSPECTED BRAIN TUMOR. AFTER BRIEF TROUBLESHOOTING, IT BECAME CLEAR THAT THE PATIENT RECORD WAS UNINTENTIONALLY MERGED WITH ANOTHER PATIENT RECORD. THE SURGEON RESOLVED THE MERGE WITH SUPPORT FROM BRAINLAB. FURTHER INVESTIGATION BY BRAINLAB UNCOVERED FOUR MORE CASES OF INCORRECT PATIENT RECORD MERGES AT THE SAME SITE THAT WERE THEREAFTER RESOLVED. ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE ISSUE WAS DETECTED BEFORE THE LOCALIZATION AND ANY SURGICAL PROCEDURE WAS PERFORMED ON THE PATIENT. THERE WAS NO NEGATIVE CLINICAL EFFECT ON THE PATIENT DUE TO THE INCORRECT MERGE OF PATIENT RECORDS, ALSO NOT DUE TO SURGERY/ANESTHESIA PROLONGATION OF CA. 30 MINUTES. THE FINAL OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED. BRAINLAB CONTINUES TO INVESTIGATE THE ISSUE AND WILL CONCLUDE ON CORRESPONDING ACTIONS AS SOON AS POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    887038 ORIGIN DATA MANAGEMENT (VERSION 3.2, SOFTWARE COMPONENT) AUTOMATED RADIOLOGICAL IMAGE PROCESSING SOFTWARE QIH BRAINLAB SE 30074-04D

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other