BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUNNELING INSTRUMENT 600MM

    MDR report key: 8541915 · Received April 23, 2019

    Report

    Report Number
    9610612-2019-00262
    Event Type
    Injury
    Date Received
    April 23, 2019
    Date of Event
    March 26, 2019
    Report Date
    May 28, 2019
    Manufacturer
    AESCULAP AG
    Product Code
    HAO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER, REGISTRATION NO. 9610612). EXEMPTION NUMBER: E2014018. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. (B)(4)) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER, REGISTRATION NO. (B)(4)). EXEMPTION NUMBER: E2014018. INVESTIGATION: A VISUAL INSPECTION WAS MADE OF THE INSTRUMENT. THE BROKEN OFF TIP AND THE TRACTION FIBER FV002201 WITH ALL COMPONENTS ARE MISSING. ONLY THE TUNNELING TUBE FV004203 AND THE HANDLE FV002200 IS AVAILABLE. FURTHERMORE, WE FOUND A BENT TUNNELING TUBE FV004203. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE LOT NUMBER (52468257) AND FOUND TO BE ACCORDING TO SPECIFICATION VALID DURING THE TIME OF PRODUCTION. THERE ARE NO SIMILAR INCIDENT THAT HAVE BEEN FILED FROM THIS BATCH. CONCLUSION AND ROOT CAUSE: IT IS HARDLY POSSIBLE TO DETERMINE AN EXACT CONCLUSION AND ROOT CAUSE WITHOUT THE BROKEN OFF TIP AND THE TRACTION FIBER (B)(4) WITH ALL COMPONENTS. THE ROOT CAUSE COULD BE USAGE RELATED. RATIONALE: ACCORDING TO THE QUALITY STANDARD AND DHR FILES A MATERIAL DEFECT AND PRODUCTION ERROR CAN BE EXCLUDED. INVESTIGATIONS LEAD TO THE ASSUMPTION THAT THE BENT TUNNELING TUBE WAS ADAPTED TO THE PATIENT'S ANATOMY ACCORDING INSTRUCTION FOR USE. WITHOUT THE BROKEN OFF TIP AND THE TRACTION FIBER (B)(4) WITH ALL COMPONENTS WE CANNOT DETERMINE THE EXACT CAUSE. THERE IS THE POSSIBILITY THAT THE BROKEN OFF ENDING OF THE TIP COULD HAVE BEEN CAUSED DUE TO BENDING CAUSED BY OVERLOAD. THEREFORE THE TIP COULD HAVE TILT AND BRAKE OFF. ACCORDING TO THE INSTRUCTIONS FOR USE THE FOLLOWING WARNING MUST BE OBSERVED: EXCERPT FROM IFU: SAFE OPERATION: WARNING: INSERT AND WITHDRAW THE TUNNELING INSTRUMENT CAREFULLY. ADAPT THE TUBE OF THE TUNNELING INSTRUMENT TO THE PATIENT'S ANATOMY. CAREFULLY PULL THE INNER LINE ON THE OTHER TIP OF THE TUNNELING INSTRUMENT UNTIL THE CATHETER HAS BEEN GUIDED THROUGH THE TUBE OF THE TUNNELING INSTRUMENT. NO CAPA NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED THE TIP OF THE INSTRUMENT BROKE AND FELL INTO THE PATIENT INTRA-OPERATIVELY. THE REPORTER INDICATED THE TIP OF THE DEVICE DETACHED FROM THE DEVICE AND REMAINED IN THE PATIENT'S BODY. IT IS UNKNOWN IF THE CORD BROKE APART OR THE TIP ITSELF BROKE. THE TIP WAS REMOVED FROM THE PATIENT, AND THE SURGICAL PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER, NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335542 TUNNELING INSTRUMENT 600MM HYDROCEPHALUS MANAGEMENT HAO AESCULAP AG FV004R 52468257

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention