BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE 3.5 SOFT KOH-EFF

    MDR report key: 7512523 · Received May 14, 2018

    Report

    Report Number
    1216677-2018-00027
    Event Type
    Malfunction
    Date Received
    May 14, 2018
    Date of Event
    March 9, 2018
    Report Date
    May 30, 2019
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HEW
    PMA / PMN Number
    K143650
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION X-NO SAMPLE RETURNED X-REVIEW DHR. ANALYSIS AND FINDINGS E-COMPLAINT (B)(4). *WAS THE COMPLAINT CONFIRMED? NO . A REVIEW OF THE 2 YEAR COMPLAINT HISTORY FOR THE STERILE 3.5 ULTEM KOH-EFF SHOWS SOME SIMILAR COMPLAINTS ON FILE. THE COMPLAINANT DID NOT PROVIDE A LOT NUMBER FOR THE AFFECTED SAMPLE. A DISTRIBUTION REPORT WAS GENERATED FOR ALL STERILE 3.5 ULTEM KOH-EFF SHIPPED TO CUSTOMER NUMBER 423415. A REVIEW OF THE DHR-AD750-KE35-207708, DHR-AD750-KE35-239039, DHR-AD750-KE35-239089, AND DHR-AD750-KE35-241282 SHOWS NO NONCONFORMITIES ASSOCIATED TO THIS COMPLAINT. THE REPORTED CONDITION COULD NOT BE VERIFIED OR CONFIRMED DUE TO THE AFFECTED SAMPLE NOT BEING RETURNED FOR INVESTIGATIVE ANALYSIS. IT SHOULD BE NOTED THAT R&D ENGINEERING IMPLEMENTED A PROACTIVE PRODUCT IMPROVEMENT TO INCREASE THE EFFECTIVENESS OF THE LATCH/LOCK (FIRST PRODUCTION RUN 8/17). IT SHOULD ALSO BE NOTED THAT PAST RETURNED DEVICE SAMPLES PRIOR TO THE CORRECTIVE ACTOIN THAT WERE RETURNED FOR SIMILAR REPORTED INCIDENTS WERE NOT REPRODUCIBLE. EVALUATION TESTS WERE PERFORMED BY R&D ENGINEERING ON IDENTICAL DEVICES BY PLACING THIRTY (30LBS) POUND WEIGHTS ATOP THE ADAPTER DRAPE WHEN LOCKED ONTO THE TUBE, AND COULD NOT REPLICATE THE REPORTED EVENTS OF THE LATCH NOT HOLDING; TESTS WERE PERFORMED IN DRY AND WET STATES.. THIS DEVICE IS OEM MANUFACTURED FOR CSI WHICH SENDS IT TO ANOTHER OUTSIDE CONTRACTOR FOR STERILIZATION AND DISTRIBUTES IT FROM FG WAREHOUSE TRUMBULL. ALL DEVICES ARE 100% INSPECTED BY THE OEM BEFORE BEING SHIPPED TO CSI IN TRUMBULL, CT. A REVIEW OF THE RISK MANAGEMENT REPORT AND DEVICE PFMEA (# 16 AND 17) (ADVINCULA DELINEATOR (DSP)) WERE PERFORMED AND BOTH DOCUMENTS ADDRESSED THE REPORTED EVENT WITH PROPER PROCESS CONTROLS OR VERIFICATION(S). THIS COMPLAINT IS BEING CLOSED IN ACCORDANCE WITH BSR-QAR-024. SHOULD THE AFFECTED SAMPLES BE RETURNED AT A LATER DATE THIS COMPLAINT WILL BE UPDATED ACCORDINGLY. *CORRECTION AND/OR CORRECTIVE ACTION IT SHOULD BE NOTED THAT R&D ENGINEERING IMPLEMENTED A PROACTIVE PRODUCT IMPROVEMENT TO INCREASE THE EFFECTIVENESS OF THE LATCH/LOCK (FIRST PRODUCTION RUN 8/17). THIS IS NOT AN ASSEMBLY ISSUE. COMPLAINTS WILL CONTINUE TO BE MONITORED TO DETERMINE IF THERE IS ANY NEW TREND FOR THIS COMPLAINT CONDITION. THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF OUR REPORTABLE EVENTS, PLEASE BE AWARE IT OCCURRED IN 2018.

    Description of Event or Problem · 0

    INITIAL COMPLAINT : LOCKING MECHANISM CAME UNDONE DURING CASE 4/25/18 FOLLOW UP RESPONSE RECEIVED: 10. PLEASE DESCRIBE WHAT WAS OBSERVED? THE SHAFT OF HE DELINEATOR PERFORATED THE UTERUS. THE LOCKING MECHANISM FAILED FROM MY OBSERVATION.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: NO SAMPLE RETURNED. REVIEW DHR. ANALYSIS AND FINDINGS: A REVIEW OF THE 2 YEAR COMPLAINT HISTORY FOR THE STERILE 3.5 ULTEM KOH-EFF SHOWS SOME SIMILAR COMPLAINTS ON FILE. THE COMPLAINANT DID NOT PROVIDE A LOT NUMBER FOR THE AFFECTED SAMPLE. A DISTRIBUTION REPORT WAS GENERATED FOR ALL STERILE 3.5 ULTEM KOH-EFF SHIPPED TO CUSTOMER NUMBER 423415. A REVIEW OF THE DHR-AD750-KE35-207708, DHR-AD750-KE35-239039, DHR-AD750-KE35-239089, AND DHR-AD750-KE35-241282 SHOWS NO NONCONFORMITIES ASSOCIATED TO THIS COMPLAINT. THE REPORTED CONDITION COULD NOT BE VERIFIED OR CONFIRMED DUE TO THE AFFECTED SAMPLE NOT BEING RETURNED FOR INVESTIGATIVE ANALYSIS. IT SHOULD BE NOTED THAT R&D ENGINEERING IMPLEMENTED A PROACTIVE PRODUCT IMPROVEMENT TO INCREASE THE EFFECTIVENESS OF THE LATCH/LOCK (FIRST PRODUCTION RUN 8/17). IT SHOULD ALSO BE NOTED THAT PAST RETURNED DEVICE SAMPLES PRIOR TO THE CORRECTIVE ACTION THAT WERE RETURNED FOR SIMILAR REPORTED INCIDENTS WERE NOT REPRODUCIBLE. EVALUATION TESTS WERE PERFORMED BY R AND D ENGINEERING ON IDENTICAL DEVICES BY PLACING THIRTY (30 LBS) POUND WEIGHTS ATOP THE ADAPTER DRAPE WHEN LOCKED ONTO THE TUBE, AND COULD NOT REPLICATE THE REPORTED EVENTS OF THE LATCH NOT HOLDING; TESTS WERE PERFORMED IN DRY AND WET STATES. A REVIEW OF THE RISK MANAGEMENT REPORT AND DEVICE PFMEA (# 16 AND 17) (ADVINCULA DELINEATOR (DSP)) WERE PERFORMED AND BOTH DOCUMENTS ADDRESSED THE REPORTED EVENT WITH PROPER PROCESS CONTROLS OR VERIFICATION(S). THIS COMPLAINT IS BEING CLOSED IN ACCORDANCE WITH (B)(4). SHOULD THE AFFECTED SAMPLES BE RETURNED AT A LATER DATE THIS COMPLAINT WILL BE UPDATED ACCORDINGLY. CORRECTIVE ACTIONS: CORRECTION AND/OR CORRECTIVE ACTION: IT SHOULD BE NOTED THAT R AND D ENGINEERING IMPLEMENTED A PROACTIVE PRODUCT IMPROVEMENT TO INCREASE THE EFFECTIVENESS OF THE LATCH/LOCK (FIRST PRODUCTION RUN 8/17). THIS COMPLAINT CONDITION IS CONSIDERED A LEVEL 3 CORRECTIVE ACTION PER (B)(4). LEVEL 3 COMPLAINTS WILL BE CONTINUOUSLY MONITORED FOR TRENDS AND ADDRESSED ACCORDINGLY. WAS THE COMPLAINT CONFIRMED? NO.

    Description of Event or Problem · 1

    INITIAL COMPLAINT: LOCKING MECHANISM CAME UNDONE DURING CASE. ON 4/25/2018 FOLLOW UP RESPONSE RECEIVED: 10. PLEASE DESCRIBE WHAT WAS OBSERVED? THE SHAFT OF THE DELINEATOR PERFORATED THE UTERUS. THE LOCKING MECHANISM FAILED FROM MY OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352526 STERILE 3.5 SOFT KOH-EFF STERILE 3.5 SOFT KOH-EFF HEW COOPERSURGICAL, INC. AD750SC-KE35 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other