BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.038" HYBRID WIRE, BOX OF 5

    MDR report key: 11766228 · Received May 3, 2021

    Report

    Report Number
    3003790304-2021-00079
    Event Type
    Malfunction
    Date Received
    May 3, 2021
    Date of Event
    April 19, 2021
    Report Date
    September 15, 2022
    Manufacturer
    EP FLEX
    Product Code
    EYA
    UDI-DI
    00821925031449
    PMA / PMN Number
    EXEMPT-EYA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE APPROVED FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD PERFORMED BY EP FLEX FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE DEVICE WAS RETURNED AND EVALUATED, AND THE PHENOMENON WAS CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, THERE WAS A SIGNIFICANT NON-UNIFORM TUNGSTEN DISTRIBUTION COMPARED TO A RANDOM FINISHED PRODUCT TEST LOT. SURFACE AREAS OF HIGH TUNGSTEN CONCENTRATION ALSO APPEARED TO HAVE DIFFERENT SURFACE TENSION OR HYDROPHOBIC CHARACTERISTICS WHICH RESISTED THE FLOW OF THE HYDROPHILIC COATING. THE OEM OBSERVED THAT THE TENSILE STRENGTH OF THESE PRODUCTS NO LONGER MEET SPECIFICATION. HOWEVER, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 1

    IN TROUBLESHOOTING THE ISSUE WITH OLYMPUS TECHNICAL SUPPORT VIA THE PHONE, THE REPORTER STATED AS A RESULT OF THE ISSUE, THE FACILITY WANTED TO PULL THE REST OF THREE (3) UN-OPENED 0.038" HYBRID WIRES FROM INVENTORY AND RETURN THE THREE UN-OPENED 0.038" HYBRID WIRES WITH THE USED 0.038" HYBRID WIRE. THE SUBJECT DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO OLYMPUS THAT DURING A THERAPEUTIC URETEROSCOPY PROCEDURE, THE DISTAL TIP OF THE 0.038" HYBRID WIRE HAD BROKEN. A SMALL SECTION OF THE HYDROPHILIC TIP CRUMBLED OFF AND FELL INSIDE THE PATIENT. THE PART THAT FELL INSIDE THE PATIENT WAS SMALL SO THAT IT WAS NOT RETRIEVED. THE FRAGMENT WAS DISCOVERED AS THE BLADDER OF THE PATIENT WAS WASHED OUT AT THE END OF THE CASE. THE PROCEDURE WAS COMPLETED WITH NO SURGICAL DELAY OR COMPLICATION TO THE PATIENT. THIS COMPLAINT IS RELATED TO PATIENT IDENTIFIERS: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662412 0.038" HYBRID WIRE, BOX OF 5 STYLET, URETERAL EYA EP FLEX GWH3805R 91905598 00821925031449

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown