BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERELINK ICP PROBE BASIC KIT

    MDR report key: 17596871 · Received August 22, 2023

    Report

    Report Number
    3013886523-2023-00277
    Event Type
    Malfunction
    Date Received
    August 22, 2023
    Date of Event
    August 2, 2023
    Report Date
    October 26, 2023
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    GWM
    UDI-DI
    10381780520672
    PMA / PMN Number
    K173192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE CERELINK SENSOR (ID 826850) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR)- PRODUCT 826850 FOR LOT 6810805 (SN (B)(6)) AND THE LOT MET SPECIFICATIONS WHEN RELEASED. FAILURE ANALYSIS - CATHETER WAS BROKEN OFF WITH THE SENSOR. NO TESTING POSSIBLE. ROOT CAUSE ANALYSIS- COULD BE DETERMINED AS A MISHANDLING OF THE CATHETER AND TROCAR. IF CUSTOMER TIGHTENS THE TROCAR TO TIGHT, IT WILL DAMAGE THE CATHETER CAUSING BREAKAGE.

    Description of Event or Problem · 0

    A FACILITY REPORTED A CERELINK SENSOR (ID 826850) LEAD BROKE WHEN THE TROCAR WAS REMOVED WHILE PASSING THE LEAD THROUGH THE SKIN DURING IMPLANTATION/PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. ACCORDING TO INFORMATION PROVIDED, IT IS UNKNOWN IF ANY PART FELL INTO THE SURGICAL SITE. THE PRODUCT WAS NOT PLUGGED INTO THE WALL AND CONNECTED TO A PATIENT WHEN THE FAILURE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249397 CERELINK ICP PROBE BASIC KIT ICP MICRSOSENSORS - CERELINK GWM INTEGRA LIFESCIENCES MANSFIELD 6810805 10381780520672

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown