BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSATION MICROSCIS S/S BAY STR 70/195MM

    MDR report key: 8741311 · Received June 27, 2019

    Report

    Report Number
    9610612-2019-00427
    Event Type
    Malfunction
    Date Received
    June 27, 2019
    Report Date
    June 27, 2019
    Manufacturer
    AESCULAP AG
    Product Code
    GZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. MANUFACTURING SITE EVALUATION: WE RECEIVED A PAIR OF SCISSORS FOR INVESTIGATION DECONTAMINATED. THE INSTRUMENT IS IN MINT CONDITION, BUT THE TIPS ARE BENT. VISUAL INVESTIGATION: THE TIPS OF BOTH BLADES ARE BENT IN THE SAME DIRECTION, MOST LIKELY CAUSED BY A DROP. THEREFORE, THE CUTTING PERFORMANCE IS NO LONGER ACCORDING TO THE SPECIFICATIONS. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE AVAILABLE LOT NUMBER AND FOUND TO BE ACCORDING TO OUR SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THIS BATCH. CONCLUSION AND ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF OUR INVESTIGATION THE ROOT CAUSE OF THE FAILURE IS MOST LIKELY RELATED TO INSUFFICIENT USAGE. RATIONALE: THE DAMAGE TO THE WORKING END WAS MOST LIKELY CAUSED BY A DROP, E.G. DURING HANDLING OR REPROCESSING. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), THE WORKING ENDS NEED TO BE PROTECTED: "PACKAGING - APPROPRIATELY PROTECT PRODUCTS WITH FINE WORKING TIPS".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE MICRO SCISSORS. DURING CEREBRO-NEURO PROCEDURE, THE MICRO-SCISSORS DID NOT CUT. IT WAS NOTED DURING THE FIRST USE OF THE 2 SCISSORS, AND THERE WAS SOME TEARING OF TISSUE. THE FIRST SCISSOR ALSO HAD A SCREW LOOSEN. NO INTERVENTION WAS REQUIRED AND THERE WAS NO SURGICAL DELAY REPORTED. THE PATIENT WAS NOT HARMED AND THERE WERE NO INJURIES OR CONSEQUENCES. ADDITIONAL INFORMATION WAS NOT PROVIDED. ASSOCIATED MEDWATCHES: (2 SCISSORS REPORTED SEPARATELY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532905 SENSATION MICROSCIS S/S BAY STR 70/195MM INSTRUMENTS FOR NEUROSURGERY GZX AESCULAP AG FM120R 52486614

    Patients

    Seq Age Sex Outcome Treatment
    1