BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYSTIC II, BELL CUP

    MDR report key: 8523503 · Received April 17, 2019

    Report

    Report Number
    1216677-2019-00054
    Event Type
    Malfunction
    Date Received
    April 17, 2019
    Date of Event
    February 6, 2019
    Report Date
    December 12, 2019
    Manufacturer
    COOPERSURGICAL INC.
    Product Code
    HDB
    PMA / PMN Number
    K011532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE E-COMPLAINT: (B)(4). INVESTIGATION: X-INITIATED MANUFACTURER'S INVESTIGATION: X-NO SAMPLE RETURNED, X-REVIEW DHR. ANALYSIS AND FINDINGS: THE EVENT REPORTED CANNOT BE VERIFIED AS THE SAMPLE WAS NOT RETURNED AT THE TIME OF THIS INVESTIGATION, AND NO RMA WAS GIVEN. SHOULD THE SAMPLE BE RETURNED AT A LATER DATE THIS COMPLAINT MAY BE REOPENED FOR ANALYSIS VERIFICATION. ALTHOUGH A ROOT CAUSE IS INDETERMINABLE WITHOUT THE ACTUAL AFFECTED SAMPLE, IT'S POSSIBLE THAT A CORRECT SEAL WAS NOT OBTAINED IN ORDER TO PRODUCE A VACUUM. INSTRUCTION FOR USE IS PROVIDED IN THE PRODUCT IFU. IT SHOULD BE NOTED THAT EACH VAD DEVICE IS INDIVIDUALLY FUNCTIONALLY TESTED FOR ACCEPTANCE; 100% FUNCTIONAL AND VISUAL ACCEPTANCE. A REVIEW OF THE WORK ORDER DHR INDICATED THAT ALL PROCESS WERE PERFORMED WITH ACCEPTANCE AND DID NOT INDICATE ANY ABNORMALITY. CORRECTION AND/OR CORRECTIVE ACTION: NONE. CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME AS THE AFFECTED DEVICE WAS NOT RETURNED FOR INVESTIGATIVE ANALYSIS AND ROOT CAUSE. WAS THE COMPLAINT CONFIRMED? NO. PREVENTATIVE ACTION ACTIVITY: COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR ANY TRENDS.

    Description of Event or Problem · 0

    COOPER SURGICAL MITYSOFT BELL CUP VACUUM. ITEM#: 10058, LOT#: 223479. NO PATIENT INJURY. "THE PROVIDER PLACED THE VACUUM ON THE FETAL HEAD, PUMPED THE HANDLE, NO SUCTION WAS AVAILABLE, PRESSURE UNATTAINABLE. THE PROVIDER STATED IT WAS AS IF THERE WAS A LEAK IN THE VACUUM." REF E-COMPLAINT: (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. REFERENCE E-COMPLAINT-(B)(4).

    Description of Event or Problem · 1

    COOPER SURGICAL MITYSOFT BELL CUP VACUUM. ITEM # 10058, LOT # 223479. NO PATIENT INJURY. "THE PROVIDER PLACED THE VACUUM ON THE FETAL HEAD, PUMPED THE HANDLE, NO SUCTION WAS AVAILABLE, PRESSURE UNATTAINABLE. THE PROVIDER STATED IT WAS AS IF THERE WAS A LEAK IN THE VACUUM." REF E-COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316891 MYSTIC II, BELL CUP MYSTIC II, BELL CUP HDB COOPERSURGICAL INC. 10058 223479

    Patients

    Seq Age Sex Outcome Treatment
    1 Other