BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYSTIC II,MUSHROOM CUP

    MDR report key: 8070352 · Received November 14, 2018

    Report

    Report Number
    1216677-2018-00071
    Event Type
    Malfunction
    Date Received
    November 14, 2018
    Date of Event
    August 23, 2018
    Report Date
    February 13, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HDB
    UDI-DI
    00888937003109
    PMA / PMN Number
    K011532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION, INITIATED MANUFACTURER'S INVESTIGATION, NO SAMPLE RETURNED, REVIEW DHR. *ANALYSIS AND FINDINGS THE REPORTED COMPLAINT EVENT CANNOT BE VERIFIED OR ANALYZED DUE TO THE ABSENCE OF THE AFFECTED MYSTIC II, MUSHROOM CUP AND PUMP DEVICE IN THAT IT WAS NOT RETURNED. SHOULD THE AFFECTED DEVICE BE RETURNED IN THE FUTURE, THE COMPLAINT MAY BE REOPENED AND AMENDED AS NEEDED. A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT CANNOT BE DETERMINED WITHOUT THE ACTUAL DEVICE USED IN THE REPORTED EVENT., HOWEVER, IN REVIEWING PAST COMPLAINT ANALYSIS AND ATTRIBUTING TO PAST POTENTIAL ROOT CAUSE, IT'S LIKELY THAT THE DEVICE MAY HAVE BEEN SUBJECTED TO USE IN A MANNER CONTRARY TO ITS INTENDED USE OR FUNCTION. A REVIEW OF THE TWO-YEAR COMPLAINT HISTORY INDICATED THAT THERE WERE NO OTHER SIMILAR COMPLAINTS REPORTED PREVIOUSLY. A REVIEW OF THE CSI MANUFACTURING ASSEMBLY PROCESS INDICATED THAT NOTHING HAD BEEN CHANGED, AND WORK INSTRUCTIONS WERE BEING PROPERLY FOLLOWED AND ADHERED TO. IT SHOULD BE NOTED THAT BOTH THE PUMP AND MUSHROOM CUP ASSEMBLY ARE 100% VISUALLY AND FUNCTIONALLY EVALUATED FOR ACCEPTABILITY. A REVIEW OF THE LOT DHR FOR WORK ORDER 230218 WAS PERFORMED AND DID NOT REVEAL ANY ABNORMALITIES. *CORRECTION AND/OR CORRECTIVE ACTION CORRECTIVE ACTION IS NOT APPLICABLE AT THIS TIME DUE TO THE ABSENCE OF THE AFFECTED SAMPLE FOR PROPER INVESTIGATIVE ANALYSIS THAT ASSISTS IN ASCERTAINING A POTENTIAL ROOT CAUSE. PER 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

    CUSTOMER STATED "ONE OF OUR CUSTOMERS RETURNED A BATCH OF (B)(4), 10057 MYSTIC II PUMP W/MUSHROOM CUP, BATCH N° 230218. (B)(4) WERE COMPLETELY BROKEN WHILE DELIVERING THE BABY, SO WE REPLACED THEM IMMEDIATELY TO SATISFY CUSTOMER. (B)(4) OF THE SAME BATCH WERE RETURNED BY THE SAME CUSTOMER AS THEY DOESN'T TRUST THE QUALITY OF THEM." 1216677-2018-00071-1 MYSTIC II MUSHROOM CUP 10057 E-COMPLAINT-(B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER STATED "ONE OF OUR CUSTOMERS RETURNED A BATCH OF 20 PCS, 10057 MYSTIC II PUMP W/MUSHROOM CUP, BATCH N° 230218. 2 PCS OF THE 10057 WERE COMPLETELY BROKEN WHILE DELIVERING THE BABY, SO WE REPLACED THEM IMMEDIATELY TO SATISFY CUSTOMER 18 PCS OF THE SAME BATCH WERE RETURNED BY THE SAME CUSTOMER AS THEY DOESN'T TRUST THE QUALITY OF THEM." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908130 MYSTIC II,MUSHROOM CUP MYSTIC II,MUSHROOM CUP HDB COOPERSURGICAL, INC. 10057 230218 00888937003109

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other