BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLASSVAN

    MDR report key: 7531889 · Received May 22, 2018

    Report

    Report Number
    1058382-2018-00004
    Event Type
    Malfunction
    Date Received
    May 22, 2018
    Date of Event
    May 14, 2018
    Report Date
    May 21, 2018
    Manufacturer
    M/S NIRAJ INDUSTRIES PVT LTD.
    Product Code
    GES
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    SC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER HAS INVESTIGATED THIS ISSUE ON THE CONTROL SAMPLES AND SAMPLES PROVIDED BY THE COMPLAINANT OF THE SAME BATCH NUMBER (171611AC). THE REPORTED PROBLEM COULD NOT BE ESTABLISHED ON EXAMINATION OF RETAINED SAMPLES AND RELATED RECORDS OF BATCH NUMBER 171611AC. THE DEVICE CHARACTERISTICS WHICH CAN INDUCE BREAKAGE OF BLADE HAVE BEEN OBSERVED WITHIN SPECIFICATIONS. 34 UNUSED SAMPLES PROVIDED BY THE COMPLAINANT ARE ALSO FOUND WITHIN THE SPECIFICATIONS WITH REGARD TO THE PARAMETERS WHICH CAN INDUCE BLADE BREAKAGE (SHARPNESS, HARDNESS, STIFFNESS AND FITMENT OF BLADES). SAMPLES EVALUATION REPORTS ARE ENCLOSED FOR YOUR READY REFERENCE. WE HAVE CLOSED THE COMPLAINT BASED ON THE RESULT OF THE MANUFACTURER'S INVESTIGATION. WE CONSIDER THIS REPORT CLOSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE #15 SURGICAL BLADE BROKE DURING THE REMOVAL OF IMPACTED 3RD MOLARS OF THE FEMALE PATIENT. THE BROKEN BLADE (FRAGMENT) WAS QUICKLY RECOVERED FROM THE PATIENT'S MOUTH AND NO FURTHER MEDICAL INTERVENTION OR ADDITIONAL TREATMENT WAS NEEDED DUE TO THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE #15 SURGICAL BLADE BROKE DURING THE REMOVAL OF IMPACTED 3RD MOLARS OF THE FEMALE PATIENT. THE BROKEN BLADE (FRAGMENT) WAS QUICKLY RECOVERED FROM THE PATIENT'S MOUTH AND NO FURTHER MEDICAL INTERVENTION OR ADDITIONAL TREATMENT WAS NEEDED DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375692 GLASSVAN SURGICAL BLADE GES M/S NIRAJ INDUSTRIES PVT LTD. 171611AC

    Patients

    Seq Age Sex Outcome Treatment
    1