BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAWS "HIQ+", 5 X 330 MM, SCISSORS, METZENBAUM

    MDR report key: 16645117 · Received March 30, 2023

    Report

    Report Number
    9610773-2023-00913
    Event Type
    Malfunction
    Date Received
    March 30, 2023
    Date of Event
    February 21, 2023
    Report Date
    April 28, 2023
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HET
    UDI-DI
    04042761010320
    PMA / PMN Number
    K944200
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE OF THE REPORTED BROKEN JAWS/MOUTH COULD NOT BE DEFINITIVELY DETERMINED, HOWEVER, BASED ON THE AVAILABLE INFORMATION PROVIDED BY THE CUSTOMER, THE ISSUE WAS LIKELY THE RESULT OF A DEVICE WEAR AND INCORRECT HANDLING/EXCESSIVE FORCE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WILL NOT BE RETURNED TO OLYMPUS FOR EVALUATION. HOWEVER, A PHOTOGRAPH OF THE DEVICE WAS PROVIDED. THE JAWS AT THE DISTAL END APPEARED TO BE INTACT, HOWEVER, THE PULL ROD (BALL) AT THE PROXIMAL END OF THE DEVICE WAS OBSERVED BROKEN OFF THE DEVICE. THE MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE AFFECTED SERIAL NUMBER WITHOUT SHOWING ANY NON-CONFORMITIES OR DEVIATIONS REGARDING THE DESCRIBED ISSUES. THE INVESTIGATION IS STILL IN PROGRESS; HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY. IN GENERAL, THE END-USER IS REQUIRED TO INSPECT THE DEVICE FOR DEFECTS, CHECK THE FUNCTION OF ALL DEVICES AND HAVE ALTERNATE EQUIPMENT PRIOR TO USE. ADDITIONAL 510(K): K944201.

    Description of Event or Problem · 0

    OLYMPUS WAS INFORMED THE CUSTOMER HIQ+, METZENBAUM GRASPING SCISSORS HAS "BROKEN PARTS OF THE JAWS". MECHANICAL MALFUNCTION DURING ASSEMBLY BY EXCESSIVE FORCE. THE CUSTOMER REPORTED PROBLEM WAS FOUND AT PREPARATION FOR USE. NO PROCEDURE INVOLVED AND NO INJURY OR IMPACT TO PATIENT OR OTHER WAS REPORTED TO OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210431 JAWS "HIQ+", 5 X 330 MM, SCISSORS, METZENBAUM METZENBAUM GRASPING SCISSORS HET OLYMPUS WINTER & IBE GMBH A64810A 19304-018 04042761010320

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown