BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM ICSI MICROPIPETS

    MDR report key: 8474106 · Received April 2, 2019

    Report

    Report Number
    1216677-2019-00143
    Event Type
    Malfunction
    Date Received
    April 2, 2019
    Date of Event
    March 25, 2019
    Report Date
    April 4, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    MQH
    UDI-DI
    20888937903090
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DISTRIBUTION HISTORY THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI IN NOV 2018. MANUFACTURING RECORD REVIEW THE DHR WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. HISTORICAL COMPLAINT REVIEW PER REVIEW OF TWO-YEAR COMPLAINT HISTORY FOR THIS SPECIFIC PART NUMBER, IT WAS CONFIRMED THAT THERE ARE NO PREVIOUS EVENTS RELATED TO MICROPIPETTES MISSING THE BEND ANGLE. PRODUCT RECEIPT 11 BOXES (10-PACK) OF LOT 1557, WERE RECEIVED, REVIEWED AND CONFIRMED THAT ALL THE UNITS PRESENTED THE FAILURE MODE, OF NOT HAVING THE ANGLE BEND. FUNCTIONAL EVALUATION REVIEWED AND CONFIRMED THAT ALL THE UNITS PRESENTED THE FAILURE MODE, OF NOT HAVING THE ANGLE BEND. ROOT CAUSE AS A RESULT OF THIS FAILURE MODE CONFIRMATION, CAPA 723 WAS OPENED TO ADDRESS THIS EVENT. PER CAPA 723, THE CAUSE FOR THIS EVENT IS COMPOSED OF THREE CONTRIBUTING FACTORS: 1. AT THE TIME OF THE EVENT, THERE WAS A GENERAL UNDERSTANDING, THAT THE LAST DIGIT OF THE PART NUMBER INDICATED THE REQUIRED ANGLE. HOWEVER, LOT 1557 WAS ONE OF THE FIRST CUSTOM ICSI MICROPIPETTES WITH PART NUMBER MICC001-30-B1.0, AND IT HAD A 0 AT THE END. AS A RESULT, IT IS PROBABLE THAT THE PRODUCTION AND QC PERSONNEL UNDERSTOOD IT HAD NO ANGLE. 2. OPPORTUNITIES WITH SPECIFICATION DRAWINGS HANDLING, THAT COULD ALSO HAD LED TO CONFUSION REGARDING THE PART ANGLE. 3. LACK OF A SYSTEMATIC VERIFICATION AS PART OF THE IN-PROCESS DEVICE HISTORY RECORD , TO ENSURE THAT MANUFACTURING EQUIPMENT AND QC INSPECTIONS WERE PROPERLY SETUP TO COMPLY WITH PART DRAWING SPECIFICATION PER THE REQUIRED WORK ORDER PART NUMBER. 1. UPDATED THE MICROPIPETTE AREA DHRS TO IMPLEMENT A SYSTEMATIC VERIFICATION CHECKLIST OF THE WO PART NUMBER, AGAINST THE REQUIRED DRAWING QUALITY DIMENSIONAL CHARACTERISTICS. 2. IMPLEMENTED A SOLUTION FOR THE OPERATOR, TO SCAN THE PART NUMBER OUT OF THE WORK ORDER, AND THAT THE DIMENSIONAL SET POINTS ARE AUTOMATICALLY SET IN THE ICSI WORK CELL. THE IMPLEMENTATION SHALL BE DONE PER APPROPRIATE VALIDATION CHANGE CONTROL AND PROCEDURES UPDATES. 3. IMPLEMENTED FOR APPROVED REVISION OF DRAWING FOR PART NUMBER MICC001-30-B1.0. ENSURE VARIANCES RELATED TO USE OF RED-LINE DRAWINGS ARE CLOSED AND THAT ONLY APPROVED DOCUMENTS ARE USED FOR PRODUCTION. ALSO ESTABLISHED CONTROLLED COPIES FOR DRAWING SPECIFICATIONS AT THE PRODUCTION AREA. 4. REVISED SOP VARIANCE PROCEDURE, TO ALIGN WITH TRUMBULL VARIANCE PROCEDURE SOP. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED 4 BOXES OF PIPETTES MICC001-30-B1.0 , BATCH NUMBER 1557 WITH DIFFERENT FEATURES BY THE ONES THEY COMMONLY RECEIVE FOR THIS REFERENCE. MICC001-30-B1.0 WAS ABNORMAL, THE TIPS PRESENT IN THE BOXES ARE FLAT SO THEY CAN USE THEM. NO PATIENT INVOLVEMENT OR ADVERSE EVENT REPORTED. 1216677-2019-00143-1 CUSTOM ICSI MICROPIPETS MICC001-30-B1 (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MICC001-30-B1.0 WAS ABNORMAL, THE TIPS PRESENT IN THE BOXES ARE FLAT SO THEY CAN USE THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269600 CUSTOM ICSI MICROPIPETS CUSTOM ICSI MICROPIPETS MQH COOPERSURGICAL, INC. MICC001-30-B1.0 1557 20888937903090

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other