BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3MM PIPET CURETTE BOX=50

    MDR report key: 7952094 · Received October 10, 2018

    Report

    Report Number
    1216677-2018-00051
    Event Type
    Malfunction
    Date Received
    October 10, 2018
    Date of Event
    September 18, 2018
    Report Date
    February 22, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HHK
    UDI-DI
    00888937003536
    PMA / PMN Number
    K001545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION. INITIATED MANUFACTURER'S INVESTIGATION REVIEW DHR INSPECT RETURNED SAMPLES. *ANALYSIS AND FINDINGS: THE THREE RETURNED MX140 SAMPLES WERE RECEIVED AND VERIFIED TO HAVE BEEN COMPLETELY SEAL POUCHED AND INTACT. THE THREE SAMPLE WERE VERIFIED TO HAVE BEEN FREE OF ANY DAMAGE AND WERE FUNCTIONALLY ACCEPTABLE; ALL THREE WERE TESTED FOR VACUUM USING WATER. ALL THREE SAMPLES PRODUCED AN ACCEPTABLE VACUUM WHERE THERE WERE NO LEAKS. THE REPORTED EVENT COULD NOT BE DUPLICATED AS REPORTED, THIS MAY BE CONSIDERED AN ISOLATED INCIDENT. THE ASSEMBLY PROCESS WAS REVIEWED AND FOUND ACCEPTABLE AND WITHOUT ALTERATIONS. ALL INVENTORY FROM THE AFFECTED LOT HAS BEEN DEPLETED AND NOT AVAILABLE FOR FURTHER VERIFICATION ANALYSIS, NO FURTHER ACTION REQUIRED AT THIS TIME. A REVIEW OF THE TWO-YEAR PRODUCT COMPLAINT HISTORY INDICATED THIS TO HAVE BEEN THE ONLY REPORTED EVENT OF ITS KIND, TRENDING WILL CONTINUE FOR THIS PRODUCT. A REVIEW OF THE PRODUCT LOT DHR WAS PERFORMED AND NO ABNORMALITIES WERE NOTED. *CORRECTION AND/OR CORRECTIVE ACTION: CORRECTIVE ACTION IS NOT APPLICABLE DUE TO THE ABSENCE OF THE ACTUAL AFFECTED DEVICE FOR INVESTIGATIVE ANALYSIS AS IT WAS NOT RETURNED TO DETERMINE A POSSIBLE ROOT CAUSE, THE OTHER THREE RETURNED SAMPLES WERE FREE OF ANY VISIBLE DAMAGE AND FUNCTIONED IN AN ACCEPTABLE MANNER. PER BSR-QAR-026, THIS COMPLAINT WILL BE MONITORED FOR TRENDING IN THAT NO INJURY WAS REPORTED TO END USER OR PATIENT. *WAS THE COMPLAINT CONFIRMED? NO.

    Description of Event or Problem · 0

    TIP OF CURETTE BROKE OFF DURING PROCEDURE. WAS RETRIEVED, NO INJURY TO PATIENT. 3MM PIPET CURETTE BOX 50 MX140 (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. THE DEVICE INVOLVED IN THE COMPLAINT HAS BEEN RETURNED BY THE CUSTOMER FOR EVALUATION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    "TIP OF CURETTE BROKE OFF DURING PROCEDURE, TOOK TIME AND USE OF SEVERAL INSTRUMENTS BUT WAS RETRIEVED NO INJURY TO PATIENT." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793150 3MM PIPET CURETTE BOX=50 3MM PIPET CURETTE BOX=50 HHK COOPERSURGICAL, INC. MX140 224216 00888937003536

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O