BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRASPING FORCEPS, OPTICAL, FOR LITHOTRIPSY, FOR 12° AND 30° TELESCOPE

    MDR report key: 15904832 · Received December 2, 2022

    Report

    Report Number
    9610773-2022-00577
    Event Type
    Malfunction
    Date Received
    December 2, 2022
    Report Date
    December 2, 2022
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    GCP
    UDI-DI
    04042761019989
    PMA / PMN Number
    K790071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. DURING INSPECTION AND TESTING, THE ALLEGATION WAS CONFIRMED DUE TO THE JAW INSERT AND LOCKING MECHANISM MALFUNCTIONING. THE WELDED CONNECTION BETWEEN THE PULL-WIRE GUIDE AND THE PULL-WIRE OF THE FORCEPS, WHICH FUNCTIONS AS OVERLOAD PROTECTION, WAS BROKEN OR THE FORCEPS OVERLOAD PROTECTION HAS BEEN PROPERLY TRIGGERED AS A RESULT OF A MASSIVE OVERLOAD IN ORDER TO PREVENT AN AXLE BREAKAGE OR SIMILAR DAMAGE IN THE JAW AREA. FORCEPS WITH TRIGGERED OVERLOAD PROTECTION ARE NON-FUNCTIONAL AND DO NOT COMPLY WITH THE CURRENT PRODUCT SPECIFICATION AND CANNOT BE FURTHER USED ACCORDING TO THE "INTENDED USE". IMPORTANT INFORMATION: TO PREVENT DAMAGE OF THIS NATURE, PRODUCT QUALITY INFORMATION (PQI) NO. 07/12 "PUNCH FOR BLADDER STONES" WAS PUBLISHED IN JULY 2015 AND DESIGN CHANGES WERE IMPLEMENTED TO PREVENT POSSIBLE BLOCKAGE OF THE JAW AFTER THE OVERLOAD PROTECTION HAS BEEN PROPERLY TRIGGERED. THE DEVICE IN QUESTION WAS MANUFACTURED AFTER OCTOBER 2015 WHICH MEANS THAT UNTIL THIS DATE THERE WAS A POSSIBILITY THAT THE JAWS REMAINED OPEN DUE TO THE APPLICATION OF EXCESSIVE FORCE ON THE OVERLOAD PROTECTION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DEVICE PROBLEM. THE DHR CONFIRMED THAT THE SUBJECT DEVICE WAS SHIPPED IN ACCORDANCE WITH THE SPECIFICATIONS. THE INVESTIGATION CONCLUDED THAT THE REPORTED PROBLEM WAS LIKELY THE FUNCTION OF THE FORCEPS BEING TESTED AND THE OVERLOAD PROTECTION WAS PROPERLY TRIGGERED AS A RESULT OF A MASSIVE OVERLOAD AND IMPROPER HANDLING. THE REASON THE OVERLOAD PROTECTION WAS ALREADY TRIGGERED BEFORE THE FIRST USE CANNOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE. A FOLLOW UP WITH THE USER FACILITY IS CURRENTLY BEING PERFORMED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Description of Event or Problem · 0

    AN OLYMPUS SALESPERSON REPORTED ON BEHALF OF THE CUSTOMER, THE WORKING END OF GRASPING FORCEPS, OPTICAL, FOR LITHOTRIPSY, FOR 12°AND 30°TELESCOPE DOES NOT CLOSE WHEN IT IS WITH A LOAD. THE SUBJECT DEVICE MALFUNCTIONED UPON INITIAL USE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR HARM ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348057 GRASPING FORCEPS, OPTICAL, FOR LITHOTRIPSY, FOR 12° AND 30° TELESCOPE OPTICAL FORCEPS GCP OLYMPUS WINTER & IBE GMBH A20710A 22303 04042761019989

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown