BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARA WATER VAPOR PROBE KIT

    MDR report key: 17842408 · Received September 29, 2023

    Report

    Report Number
    1216677-2023-00134
    Event Type
    Injury
    Date Received
    September 29, 2023
    Date of Event
    August 16, 2022
    Report Date
    November 29, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    MNB
    UDI-DI
    888937026887
    PMA / PMN Number
    P160047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    DISTRIBUTION HISTORY: THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI ON 01/07/2021 UNDER WORK ORDER (B)(4). MANUFACTURING RECORD REVIEW: DHR WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: INCOMING INSPECTION RECORD REVIEW NOT APPLICABLE TO THIS PRODUCT. SERVICE HISTORY RECORD: SERVICE HISTORY RECORD NOT APPLICABLE TO THIS PRODUCT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY DID NOT SHOW SIMILAR REPORTED COMPLAINT CONDITION. 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 UNIT/PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. ROOT CAUSE: NO DEFINITIVE ROOT CAUSE FOR THIS ISSUE COULD BE RELIABLY DETERMINED AT THIS TIME, SINCE THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION NOR VERIFICATION. WITH THE INFORMATION PROVIDED, A ROOT CAUSE ANALYSIS CANNOT BE DEFINITIVELY PERFORMED. IT IS UNKNOWN IF THE CUSTOMER USED A SIZER (KCP) TO DETERMINE THE PROPER SIZE KOH-EFFICIENT TO USE. THIS IS LISTED UNDER THE DFU OF THE PRODUCT (ARCHKOHADV-DFU). AS A WAY OF IMPROVING THE MANUFACTURING PROCESS, CSI STAFFORD HAS IMPLEMENTED 100% IN PROCESS INSPECTION OF THE PRODUCT VIA BEND TESTING AND PULL TESTING, FOLLOWED BY AN AQL QC INSPECTION REQUIRING THE THAT THE UNITS ALSO PASS A BEND AND PULL TEST. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE ROOT CAUSE CANNOT BE RELIABLY DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENT THAT SHE UNDERWENT A MARA ABLATION IN (B)(6) 2022 TO TREAT HER FIBROIDS. PATIENT STATES THAT SHE COULD NOT TOLERATE THE PAIN OF THE PROCEDURE AFTER THIRTY SECONDS, SO THE PROCEDURE WAS ABORTED PREMATURELY. HOWEVER, PATIENT SAYS THAT THE PROCEDURE STOPPED HER BLEEDING COMPLETELY. EIGHT MONTHS POST PROCEDURE, PATIENT STATES THAT SHE EXPERIENCED HORRIBLE PELVIC PAIN. UPON CONSULTATION, PATIENT CLAIMS THAT SHE WAS TOLD THAT THE PROCEDURE HAD FAILED AND THAT SHE HAD HALF A LITER OF BLOOD IN HER ABDOMEN. BLOOD WAS DRAINED. PATIENT ALLEGEDLY TOLD TO TAKE HORMONES TO STOP THE BLEEDING UNTIL SHE REACHED FULL MENOPAUSE OR HAD A HYSTERECTOMY. FOLLOW-UP WITH PATIENT CONDUCTED, BUT NO ADDITIONAL INFORMATION WAS AVAILABLE. 1216677-2023-00133 DDK-16-050 MARA PROBE 2023-09-0000466.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345147 MARA WATER VAPOR PROBE KIT WATER VAPOUR ENDOMETRIAL-ABLATION APPLICATOR MNB COOPERSURGICAL, INC. DDK-16-050 UNKNOWN 888937026887

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention