BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    F-R BANDS,30 PROCEDURE

    MDR report key: 15493547 · Received September 27, 2022

    Report

    Report Number
    3003790304-2022-00253
    Event Type
    Malfunction
    Date Received
    September 27, 2022
    Date of Event
    August 31, 2022
    Report Date
    June 16, 2023
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    KNH
    UDI-DI
    00821925032972
    PMA / PMN Number
    P870076
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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. IT HAS BEEN OVER 1 YEAR SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE APPLICATOR OR OTHER RING BANDS WERE NOT RETURNED FOR EVALUATION. THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED. THE EVENT IS ADDRESSED IN THE INSTRUCTIONS FOR USE WHICH STATE: "FALOPE-RING BAND(S) MAY BE INADVERTENTLY DROPPED INTO THE ABDOMINAL CAVITY AND NOT RECOVERED. NO UNTOWARD EFFECTS HAVE BEEN ASSOCIATED WITH UNRECOVERED DEVICES." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION AND/OR NEW INFORMATION RECEIVED.

    Additional Manufacturer Narrative · 0

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE DEFINITIVE CAUSE OF THE USER'S EXPERIENCE CANNOT BE DETERMINED AT THIS TIME. THE INVESTIGATION IS ONGOING. THIS REPORT WILL BE UPDATED UPON COMPLETION OF THE INVESTIGATION OR UPON RECEIPT OF ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 0

    THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT WAS RECEIVED FROM THE CUSTOMER: THE PROCEDURE BEING PERFORMED WAS A LAPAROSCOPIC ATTEMPTED BILATERAL TUBAL LIGATION WITH FALOPE-RINGS. THE PATIENT WAS DISCHARGED AFTER THE PROCEDURE. THERE IS NO PLAN TO RETRIEVE THE FALOPE-RING FROM THE PATIENT'S ABDOMEN. THE PATIENT HAS NOT EXPERIENCED ANY ADVERSE EFFECTS AS A RESULT OF THIS OCCURRENCE. THREE PACKAGES OF FALOPE-RINGS WERE OPENED DURING THE PROCEDURE (LOT KR973924, 324909.MAH 417884).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS DURING AN UNSPECIFIED PROCEDURE USING FALOPE RING BANDS, THE PHYSICIAN MISFIRED ONE FALOPE RING BAND AND IT WAS LEFT IN THE PATIENT. THERE ARE NO REPORTED ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE. ADDITIONAL DETAILS REGARDING THE PATIENT AND REPORTED EVENT HAVE BEEN REQUESTED. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2045513 F-R BANDS,30 PROCEDURE DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE KNH GYRUS ACMI, INC. FRB-30 UNKNOWN 00821925032972

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female