BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE BIOPSY NEEDLE WITH MARKER PLATES

    MDR report key: 9325687 · Received November 15, 2019

    Report

    Report Number
    9611612-2019-00036
    Event Type
    Malfunction
    Date Received
    November 15, 2019
    Date of Event
    February 15, 2019
    Report Date
    February 19, 2020
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    HAW
    UDI-DI
    04048223029503
    PMA / PMN Number
    K060808
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE IS MANUFACTURED EXCLUSIVELY FOR BRAINLAB AG TO BE USED WITH THE STEREOTACTIC AND NAVIGATION INSTRUMENTS. CURRENTLY THE DATA IS QUITE POOR AND INVESTIGATIONS ARE ONGOING. MFR PAJUNK GMBH MEDIZINTECHNOLOGIE IS IN CONTACT WITH THE INITALLY REPORTING HOSPITAL AS WELL AS WITH DISTRIBUTOR/ CUSTOMER BRAINLAB IN ORDER TO FIND OUT MORE DETAILS. TREND ANALYSIS AS WELL AS BATCH RECORD DO NOT INDICATE ANY ADVERSE RESULT NOR ABNORMALITY. THIS IS THE FIRST REPORTED INCIDENT OF THIS KIND WITH THE REPORTED DEVICE MALFUNCTION. THE DEVICE URGENTLY NEEDS TO BE ANALYZED. AS SOON AS MORE INFORMATION IS AVAILABLE AN UPDATED REPORT WILL BE SENT IN TO THE FOOD AND DRUG ADMINISTRATION. 2019-12-17 WE RECEIVED THE FOLLOWING: "OUR CLINICAL SPECIALIST IS IN CONTACT WITH MRS. (B)(6), THE ADMINISTRATIVE NURSE AT (B)(6) AND THEY INFORMED US THAT THE INCIDENT OCCURRED WITH DR. (B)(6) AND (B)(6) . THE BIOPSY NEEDLE WAS CLEARED BY (B)(6) RISK MANAGEMENT TO BE SENT OFF TO THE MANUFACTURER, HOWEVER, BY THE TIME THEY RECEIVED APPROVAL THE DEVICE WENT MISSING. (B)(6) IS CURRENTLY INVESTIGATING THE LOCATION OF THE DEVICE, AND WILL INFORM US ONCE LOCATED BY EMAIL. MRS. (B)(6) IS ALSO IN CONTACT WITH (B)(6) (WHO SUBMITTED THE REPORT TO FDA) FROM (B)(6) RISK MANAGEMENT AND WILL EMAIL US WITH AN UPDATE ONCE AVAILABLE. WE ARE WAITING ON FEEDBACK REGARDING MORE COMPLETE DESCRIPTION OF THIS INCIDENT FROM DR. (B)(6) AND (B)(6) ." 2020-02-07 UPON REQUEST WE DID RECEIVE THE FOLLOWING: "BASED ON INFORMATION PROVIDED BY THE HOSPITAL ADMINISTRATIVE NURSE MS. (B)(6), THE BIOPSY NEEDLE WAS CLEARED BY (B)(6) RISK MANAGEMENT TO BE SENT OFF TO THE MANUFACTURER, HOWEVER, BY THE TIME THEY RECEIVED APPROVAL THE DEVICE WENT MISSING. BRAINLAB FOLLOWED UP WITH MS. (B)(6) BUT DID NOT GET ANY FURTHER INVESTIGATION RESULT ABOUT THE LOCATION OF THE BIOPSY NEEDLE. BASED ALSO ON INFORMATION PROVIDED MS. (B)(6), THE INCIDENT OCCURRED WITH DR. (B)(6) AND (B)(6). BRAINLAB REPRESENTATIVE MET WITH DR. (B)(6) AND (B)(6) AND THEY BOTH DO NOT RECALL THE EVENTS THAT OCCURRED IN (B)(6) 2019. DR. (B)(6) EXPRESSED THAT THEY HAVE NOT HAD ANY ISSUES USING THE BIOPSY NEEDLE SINCE.". BASED ON RISK ASSESSMENT AND CLINICAL ASSESSMENT FILE IS CONSIDERED AS CLOSED.

    Description of Event or Problem · 0

    (B)(4). USER FACILITY REPORT NUMBER:(B)(4). INITIAL REPORTERS NARRATIVE: DESCRIBE THE EVENT OR PROBLEM: OPERATING ROOM PERFORMED A STEREOTACTIC BIOPSY ON THIS PT WHERE HE USES THE DISPOSABLE BIOPSY NEEDLE KIT. REF#41778C. BIOPSY NEEDLE MALFUNCTIONED. THE TIP WAS NOT OPENING AND CLOSING AS INSTRUCTED ON PORT. DRS DID TROUBLESHOOT THE ISSUE AND NOTED IT WAS NOT FUNCTIONING PROPERLY. DID NOT USE THIS BIOPSY NEEDLE ONCE NOTED. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : STEREOTACTIC BIOPSY. VLHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY) : DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO. THE DEVICE IS MANUFACTURED BY PAJUNK GMBH MEDIZINTECHNOLOGIE EXCLUSIVELY FOR BRAINLAB AG AND DISTRIBUTED THROUGH BRAINLAB IN THE UNITED STATES OF AMERICA.

    Additional Manufacturer Narrative · 1

    DEVICE IS MANUFACTURED EXCLUSIVELY FOR BRAINLAB AG TO BE USED WITH THE STEREOTACTIC AND NAVIGATION INSTRUMENTS. CURRENTLY THE DATA IS QUITE POOR AND INVESTIGATIONS ARE ONGOING. MFR (B)(4) GMBH MEDIZINTECHNOLOGIE IS IN CONTACT WITH THE INITIALLY REPORTING HOSPITAL AS WELL AS WITH DISTRIBUTOR/ CUSTOMER BRAINLAB IN ORDER TO FIND OUT MORE DETAILS. TREND ANALYSIS AS WELL AS BATCH RECORD DO NOT INDICATE ANY ADVERSE RESULT NOR ABNORMALITY. THIS IS THE FIRST REPORTED INCIDENT OF THIS KIND WITH THE REPORTED DEVICE MALFUNCTION. THE DEVICE URGENTLY NEEDS TO BE ANALYZED. AS SOON AS MORE INFORMATION IS AVAILABLE AN UPDATED REPORT WILL BE SENT IN TO THE FOOD AND DRUG ADMINISTRATION.

    Description of Event or Problem · 1

    IRN#: (B)(4). USER FACILITY REPORT NUMBER: (B)(4).DESCRIBE THE EVENT OR PROBLEM: OR . PERFORMED A STEREOTACTIC BIOPSY ON THIS PT WHERE HE USES THE DISPOSABLE BIOPSY NEEDLE KIT. REF# (B)(4). BIOPSY NEEDLE MALFUNCTIONED . THE TIP WAS NOT OPENING AND CLOSING AS INSTRUCTED ON PORT. DRS DID TROUBLESHOOT THE ISSUE AND NOTED IT WAS NOT FUNCTIONING PROPERLY. DID NOT USE THIS BIOPSY NEEDLE ONCE NOTED. WHAT WAS THE ORIGINAL INTENDED PROCEDURE?: STEREOTACTIC BIOPSY. VLHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY): DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO;THE DEVICE IS MANUFACTURED BY (B)(4) GMBH MEDIZINTECHNOLOGIE EXCLUSIVELY FOR BRAINLAB AG AND DISTRIBUTED THROUGH BRAINLAB IN THE UNITED STATES OF AMERICA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1120133 DISPOSABLE BIOPSY NEEDLE WITH MARKER PLATES NEUROLOGICAL STEREOTACTIC INSTRUMENT HAW PAJUNK GMBH MEDIZINTECHNOLOGIE 41778C 1178 04048223029503

    Patients

    Seq Age Sex Outcome Treatment
    1 11 MO Other| R