BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAINPRO BIOPSIEKANÜLEN SET

    MDR report key: 18787136 · Received February 27, 2024

    Report

    Report Number
    9611612-2024-00003
    Event Type
    Malfunction
    Date Received
    February 27, 2024
    Date of Event
    November 28, 2023
    Report Date
    February 27, 2024
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    HAW
    PMA / PMN Number
    K060808
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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 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 1491 WITH THE MANUFACTURING DATE 2023-05-16 AND THE EXPIRY DATE 2028-05-15. 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.

    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.

    Description of Event or Problem · 0

    IRN# 055-24_867. BIOPSY NEEDLE NOT RECOGNIZED BY CRANIAL 3.X SOFTWARE (INSTRUMENT OPTIONS) DURING CASE: DURING TECHNICAL INVESTIGATION BRAINLAB DETERMINED THE FOLLOWING CONTRIBUTING ROOT CAUSE FACTOR (ONE OUT OF THREE FACTORS WHICH LED TO THE DEVIATING BIOPSY PATH): IMAGE DATA SHOW THAT THE TRAJECTORY IS AT THE EDGE OF THE BURR HOLE/NEAR BONE, WHICH COULD HAVE LED TO BENDING OF THE BRAINLAB-DISTRIBUTED BIOPSY NEEDLE WHEN MAKING CONTACT WITH THE BONE DURING INSERTION AND HAVE LED TO A DEVIATION OF THE NEEDLE TIP. FURTHER, THE NEEDLE WAS USED FOR THIS PROCEDURE WITHOUT A STOPPER, WHICH IS NOT RECOMMENDED. THUS, THE ACTUAL DEPTH OF THE NEEDLE COULD NOT BE TRACKED BY THE USER, WHICH ALLOWED FOR A TRAJECTORY BEYOND THE EXPECTED TARGET.

    Description of Event or Problem · 0

    IRN# (B)(4). BIOPSY NEEDLE NOT RECOGNIZED BY CRANIAL 3.X SOFTWARE (INSTRUMENT OPTIONS) DURING CASE: DURING TECHNICAL INVESTIGATION BRAINLAB DETERMINED THE FOLLOWING CONTRIBUTING ROOT CAUSE FACTOR (ONE OUT OF THREE FACTORS WHICH LED TO THE DEVIATING BIOPSY PATH): IMAGE DATA SHOW THAT THE TRAJECTORY IS AT THE EDGE OF THE BURR HOLE/NEAR BONE, WHICH COULD HAVE LED TO BENDING OF THE BRAINLAB-DISTRIBUTED BIOPSY NEEDLE WHEN MAKING CONTACT WITH THE BONE DURING INSERTION AND HAVE LED TO A DEVIATION OF THE NEEDLE TIP. FURTHER, THE NEEDLE WAS USED FOR THIS PROCEDURE WITHOUT A STOPPER, WHICH IS NOT RECOMMENDED. THUS, THE ACTUAL DEPTH OF THE NEEDLE COULD NOT BE TRACKED BY THE USER, WHICH ALLOWED FOR A TRAJECTORY BEYOND THE EXPECTED TARGET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1538265 BRAINPRO BIOPSIEKANÜLEN SET BRAINPRO CLASS III BIOPSY CANNULAE SET, PRODUCT CODE:HAW HAW PAJUNK GMBH MEDIZINTECHNOLOGIE 41779C 1491

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention