BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPLORA CURETTE 3MM WITH

    MDR report key: 14695202 · Received June 15, 2022

    Report

    Report Number
    1216677-2022-00180
    Event Type
    Malfunction
    Date Received
    June 15, 2022
    Date of Event
    June 8, 2022
    Report Date
    August 25, 2022
    Manufacturer
    COOPERSURGICAL INC.
    Product Code
    HHK
    PMA / PMN Number
    K001545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL, INC. IS CURRENLTY INVESTIGATING THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: X-NO SAMPLE RETURNED. X-REVIEW DHR. *ANALYSIS AND FINDINGS COMPLAINT (B)(4). DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 10/15/2021 UNDER WO #309890. MANUFACTURING RECORD REVIEW: DHR 309890 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: NOT APPLICABLE. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED NO SIMILAR REPORTED COMPLAINT CONDITION. PRODUCT RECEIPT: THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO CSI. 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. *CORRECTION AND/OR CORRECTIVE ACTION LOT #309890 WAS NO LONGER AVAILABLE IN STOCK FOR A REVIEW OF ADDITIONAL UNITS. A REVIEW OF THE SLIDE MARKER, MIL0161, REVEALS IT IS MADE OF LDPE AND ITS FUNCTION IS TO ACT AS A MARKER AND EXPECTED TO HAVE MODERATE CONTACT WITH THE PATIENT WITH NO REACTION EXPECTED. A REVIEW OF RM-TECH-022 LISTS OUT TOXICITY TESTING EXECUTED ON ENG-TEST-10409-R FOR UP TO A 48 HOUR PERIOD WITH A "GRADE 0" RESPONSE. THIS EQUATES TO DISCRETE INTRACYTOPLASMIC GRANULES WITH NO CELL LYSIS OR REDUCTION IN CELL GROWTH. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. *PREVENTATIVE ACTION ACTIVITY COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Description of Event or Problem · 0

    WHAT ARE THE DETAILS OF THE COMPLAINT? CLIP ON CURETTE SNAPPED OFF WHILE INSERTED DURING PROCEDURE. *DID THE PHYSICIAN PERFORM ANY EXTRA STEP TO COMPLETE THE PROCEDURE? PROVIDER ATTEMPTED TO LOCATE, WAS UNSUCCESSFUL. 1216677-2022-00180 EXPLORA CURETTE 3MM WITH MX120 E-COMPLAINT-(B)(4).

    Description of Event or Problem · 0

    *WHAT ARE THE DETAILS OF THE COMPLAINT? CLIP ON CURETTE SNAPPED OFF WHILE INSERTED DURING PROCEDURE. *DID THE PHYSICIAN PERFORM ANY EXTRA STEP TO COMPLETE THE PROCEDURE? PROVIDER ATTEMPTED TO LOCATE, WAS UNSUCCESSFUL. 1216677-2022-00180 EXPLORA CURETTE 3MM WITH MX120 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735907 EXPLORA CURETTE 3MM WITH EXPLORA CURETTE 3MM WITH HHK COOPERSURGICAL INC. MX120 309890

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other