BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UTERINE EXPLORA CURETTE - MODEL I

    MDR report key: 22479256 · Received July 11, 2025

    Report

    Report Number
    1216677-2025-00038
    Event Type
    Injury
    Date Received
    July 11, 2025
    Date of Event
    October 23, 2024
    Report Date
    August 27, 2025
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HHK
    UDI-DI
    00888937003505
    PMA / PMN Number
    K001545
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE LOCATION IS UNKNOWN. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    DISTRIBUTION HISTORY: THE LOT NUMBER WAS NOT PROVIDED, SO A MANUFACTURE DATE, DHR NUMBER AND SHIP DATE ARE NOT AVAILABLE. MANUFACTURING RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED BECAUSE THE COOPER LOT NUMBER WAS NOT PROVIDED. HOWEVER, IT SHOULD BE NOTED AT THE TIME OF MANUFACTURE, RECORDS FROM EACH LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL COOPERSURGICAL QUALITY RELEASE SPECIFICATIONS. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT: THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. VISUAL EVALUATION: EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. FUNCTIONAL EVALUATION: EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. ROOT CAUSE: WHILE NO DEFINITIVE ROOT CAUSE COULD BE RELIABLY DETERMINED, THE POTENTIAL ROOT CAUSE MAY BE THAT THE YELLOW SLIDE MARKER BECAME DISLODGED DURING THE PROCEDURE AND REMAINED IN THE VAGINA UNTIL IT WAS EXPELLED DURING A SHOWER. THIS IS BASED ON THE DETAILS OF THE COMPLAINT. THE YELLOW SLIDE MARKER IS SNAPPED ONTO THE CURETTE DURING ASSEMBLY. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE USER FACILITY VIA MEDWATCH: ON [REDACTED] 2024, THE PATIENT WAS IN THE OFFICE AND HAD A SIS PROCEDURE TO EVALUATE POST-MENOPAUSAL BLEEDING. THE PATIENT UNDERWENT A PELVIC SONOGRAM AND A UTERINE BIOPSY. NO COMPLICATIONS WERE NOTED. ON [REDACTED] 2025, THE PATIENT SENT A MESSAGE TO THE OFFICE THAT SHE HAD A YELLOW PLASTIC CLIP COME OUT OF HER VAGINA WHILE IN THE SHOWER FOLLOWING INTERCOURSE. SHE HAD REPORTED THAT HER HUSBAND MENTIONED FEELING A HARD OBJECT INSIDE OF HER VAGINA WITH INTERCOURSE PREVIOUSLY. THE PATIENT WAS SEEN IN THE OFFICE FOR HER ANNUAL EVALUATION TO EVALUATE FURTHER, IT DOES NOT APPEAR THERE WAS SIGNIFICANT INJURY. THE PATIENT WAS DIAGNOSED WITH BACTERIAL VAGINITIS AT THE FOLLOW UP APPOINTMENT AND TREATED WITH DOXYCYCLINE. MX120 UTERINE EXPLORA (B)(4).

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762778 UTERINE EXPLORA CURETTE - MODEL I 3MM OD CURETTE WITH VACU-LOK SYRINGE HHK COOPERSURGICAL, INC. MX120 UNKNOWN 00888937003505

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Other