BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE

    MDR report key: 16710544 · Received April 10, 2023

    Report

    Report Number
    9610773-2023-01011
    Event Type
    Malfunction
    Date Received
    April 10, 2023
    Date of Event
    March 13, 2023
    Report Date
    July 14, 2023
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GCP
    UDI-DI
    04042761006361
    PMA / PMN Number
    K790071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND REPAIR. THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, THE ROOT CAUSE OF THE REPORTED DEFECT CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY. IN GENERAL, THE CUSTOMER IS REQUIRED TO INSPECT THE DEVICE FOR DEFECTS, CHECK THE FUNCTION OF ALL DEVICES AND HAVE ALTERNATE EQUIPMENT PRIOR TO USE. MANUFACTURING DATE: COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE. ADDITIONAL PMA/510(K): K897003/ K904939.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND DEVICE EVALUATION. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE FINDINGS ARE AS FOLLOWS: THE INSERTION TUBE WAS FOUND TO BE BROKEN/DETACHED. 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 REPORTED EVENT WAS LIKELY DUE TO EXCESSIVE FORCE BY THE USER. THIS SUPPLEMENTAL REPORT INCLUDES A CORRECTION TO G2 TO PROVIDE INFORMATION THAT WAS INADVERTENTLY NOT INCLUDED IN THE INITIAL MEDWATCH. ALSO, AN UPDATE HAS BEEN MADE TO H3. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO OLYMPUS THAT A TELESCOPE HAD AN INSERTION TUBE THAT WAS BROKEN/DETACHED. THE REPORTED ISSUE WAS BOUND DURING MAINTENANCE OF THE DEVICE. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1721408 TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE ENDOSCOPE GCP OLYMPUS WINTER & IBE GMBH A4674A 210454 04042761006361

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown