BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAINPRO BIOPSIEKANÜLEN SET

    MDR report key: 18718996 · Received February 16, 2024

    Report

    Report Number
    9611612-2024-00001
    Event Type
    Malfunction
    Date Received
    February 16, 2024
    Date of Event
    December 13, 2023
    Report Date
    February 15, 2024
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    HAW
    PMA / PMN Number
    K060808
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS STILL RUNNING. AS SOON AS FURTHER INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SENT IN TO THE AGENCY. THE CLAIMED BRAINPRO BIOPSY NEEDLE FROM THE SET ART.NO. 41779C THAT WE HAVE DELIVERED TO BRAINLAB IS FOR THE BRAINLAB COMPLETE SYSTEM FOR BRAIN BIOPSIES IN WHICH OUR PRODUCT IS INTEGRATED AND USED BY BRAINLAB. WE SUPPLY A CLASS III PRODUCT TO THIS SYSTEM. THE PRODUCT CODE IS THEREFORE SELECTED AS HAW AND ENTERED AS SUCH UNDER PART D / D2B.

    Additional Manufacturer Narrative · 0

    EVENT TOOK PLACE IN USA. BASED ON ANALYSIS, RISK ASSESSMENT, RISK PROFILE AND CLINICAL MONITORING THIS FILE IS CONSIDERED AS CLOSED. IN CASE NEW INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SENT TO THE AGENCY. THE CLAIMED BRAINPRO BIOPSY NEEDLE FROM THE SET ART.NO. 41779C THAT WE HAVE DELIVERED TO BRAINLAB AG IS FOR THE BRAINLAB COMPLETE SYSTEM FOR BRAIN BIOPSIES IN WHICH OUR PRODUCT IS INTEGRATED AND USED BY BRAINLAB. WE SUPPLY A CLASS III PRODUCT TO THIS SYSTEM. THE PRODUCT CODE IS THEREFORE SELECTED AS HAW AND ENTERED AS SUCH UNDER PART D / D2B. DUE TO THE FACT THAT NO FAILURE PRODUCT, PHOTOS OR VIDEOS WERE SENT AND NO LOT NO. WAS TRANSMITTED, WE HAVE CHECKED TWO BATCHES THAT WERE LAST SOLD TO BRAINLAB AG. ONE OF THEM IS REGISTERED IN THE DOCUMENT LOT.-NO 1507 WITH THE PRODUCTION DATE 2023-09-27 AND THE EXPIRY DATE 2028-09-26. THIS PRODUCT ANALYSIS WAS CARRIED OUT ON THE BASIS OF ALL THE INFORMATION PROVIDED AND THE INTERNAL REVIEW AT PAJUNK. BASED ON ANALYSIS, RISK ASSESSMENT, RISK PROFILE AND CLINICAL MONITORING. THIS FILE IS CONSIDERED AS CLOSED. IN CASE NEW INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SENT TO THE AGENCY.

    Description of Event or Problem · 0

    IRN# (B)(4). BIOPSY NEEDLE SKIVED OFF THE TOUGH EXTERIOR OF THE LESION LEADING TO NO DIAGNOSTIC TISSUE BEING COLLECTED. MOST LIKELY DUE TO ANATOMICAL STRUCTURE DEFLECTS THE NEEDLE AWAY FROM THE TRAJECTORY CAUSING IT TO BEND ONCE THE NEEDLE APPROACHES THE BRAINSTEM.

    Description of Event or Problem · 0

    IRN# 045-24_864. BIOPSY NEEDLE SKIVED OFF THE TOUGH EXTERIOR OF THE LESION LEADING TO NO DIAGNOSTIC TISSUE BEING COLLECTED. MOST LIKELY DUE TO ANATOMICAL STRUCTURE DEFLECTS THE NEEDLE AWAY FROM THE TRAJECTORY CAUSING IT TO BEND ONCE THE NEEDLE APPROACHES THE BRAINSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880907 BRAINPRO BIOPSIEKANÜLEN SET BRAINPRO CLASS III BIOPSY CANNULAE SET, PRODUCT CODE:HAW HAW PAJUNK GMBH MEDIZINTECHNOLOGIE 41779C 1507

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention