BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUNNELING INSTRUMENT 600MM

    MDR report key: 8613643 · Received May 15, 2019

    Report

    Report Number
    9610612-2019-00304
    Event Type
    Injury
    Date Received
    May 15, 2019
    Date of Event
    April 18, 2019
    Report Date
    May 30, 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. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER, REGISTRATION NO. 9610612). EXEMPTION NUMBER: E2014018. INVESTIGATION: THE INVESTIGATION WAS CARRIED OUT VISUALLY AND MICROSCOPICALLY. A VISUAL INSPECTION WAS MADE OF THE INSTRUMENT. HERE WE FOUND NO BROKEN OFF AREA OR A BROKEN OFF PART. WE ONLY DETECTED VISIBLE DAMAGE INFORM OF GROOVES, SCRATCHES AND QUIRKS. BATCH HISTORY REVIEW: A REVIEW OF THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS IS NOT POSSIBLE BECAUSE THE BATCH NUMBER IS UNKNOWN. CONCLUSION AND ROOT CAUSE: WE CANNOT DETERMINE THE DESCRIBED ERROR. RATIONALE: WE CANNOT DETERMINED THE DESCRIBED ERROR. THERE IS THE POSSIBILITY THAT ANOTHER USED INSTRUMENT WAS SENT FOR ANALYSIS. INVESTIGATION LEAD TO THE ASSUMPTION THAT THE GROOVES, SCRATCHES AND QUIRKS HAVE BEEN CAUSED BY USING THE INSTRUMENT. POSSIBLY THIS HAS BEEN CAUSED BY AN IMPROPER HANDLING. 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. 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 CORRECTIVE/PREVENTIVE ACTIONS NEEDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE TIP DETACHED INTRAOPERATIVELY. DURING A SURGICAL PROCEDURE, THE TIP OF THE DEVICE DETACHED IN THE SUBCUTANEOUS PART OF THE BODY. THE SURGEON NOTICED UPON REMOVAL OF THE DEVICE THAT THE TIP WAS MISSING. A SKIN INCISION WAS ADDED TO REMOVE THE BROKEN END. IT IS UNKNOWN IF X-RAYS WERE TAKEN TO DETERMINE THE LOCATION OR TO CONFIRM ALL PIECES WERE REMOVED. NO PATIENT INFORMATION HAS BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER, NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407434 TUNNELING INSTRUMENT 600MM HYDROCEPHALUS MANAGEMENT HAO AESCULAP AG FV004R

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention