BEUDAMED
    FDA Adverse Event Injury Summary report: N

    H/S CATH

    MDR report key: 16788267 · Received April 21, 2023

    Report

    Report Number
    1216677-2023-00064
    Event Type
    Injury
    Date Received
    April 21, 2023
    Date of Event
    January 1, 2017
    Report Date
    June 22, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    LKF
    PMA / PMN Number
    K961752
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DISTRIBUTION HISTORY: THE PRODUCT NUMBER OR 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 A COOPER PART NUMBER OR 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. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: SERVICE HISTORY NOT APPLICABLE FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED NO 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: ROOT CAUSE NOT APPLICABLE AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED.

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE CONDITION REPORTED IN THE JSLS RESEARCH ARTICLE "FLUOROSCOPICALLY-GUIDED HYSETEROSCOPIC TUBAL CANNULATION : A PROCEDURE FOR PROXIMAL TUBAL OBSTRUCTION " PUBLISHED OCTOBER - DECEMBER 2022 VOLUME 26 ISSUE 4 E2022.00047.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    PER JSLS RESEARCH JOURNAL ARTICLE : ASYMPTOMATIC PERI-ISTHMIC TUBAL PERFORATION PROCEDURE WAS TERMINATED AND NOT RESCHEDULED AT ANOTHER TIME BECAUSE PATENCY WAS ACHIEVED ON THE CONTRALATERAL TUBE. NO POSTOPERATIVE COMPLICATIONS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965642 H/S CATH H/S CATH LKF COOPERSURGICAL, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other