BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UTERINE MANIPULATOR TIP L

    MDR report key: 13262844 · Received January 16, 2022

    Report

    Report Number
    1216677-2021-00334
    Event Type
    Malfunction
    Date Received
    January 16, 2022
    Date of Event
    December 14, 2021
    Report Date
    March 28, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    LKF
    PMA / PMN Number
    K932115
    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

    COOPERSURGICAL , INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL , INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: NO SAMPLE RETURNED: REVIEW DHR *ANALYSIS AND FINDINGS: DISTRIBUTION HISTORY: THE LOT NUMBER OF THE COMPLAINANT PRODUCT WAS NOT PROVIDED. HOWEVER, PRODUCT WAS SHIPPED TO THIS CUSTOMER FROM LOT 307826 IN NOVEMBER 2021 (FINAL ASSEMBLY MANUFACTURED AT CSI IN AUGUST 2021) AND LOT 309996 IN NOVEMBER 2021 (FINAL ASSEMBLY MANUFACTURED AT CSI IN SEPTEMBER 2021). THESE WERE THE ONLY SHIPMENTS TO THIS CUSTOMER IN THE PAST 2 YEARS. MANUFACTURING RECORD REVIEW DHR'S FOR LOT NUMBERS 307826 AND 309996 WERE REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW IQC RECORD-21-09-15-008, IQC RECORD-21-08-18-004, IQC RECORD-21-07-24-001 AND IQC RECORD-21-07-20-010 WERE REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. SERVICE HISTORY RECORD: SERVICE HISTORY NOT APPLICABLE FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY DID NOT SHOW SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT: THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. VISUAL EVALUATION: EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. FUNCTIONAL EVALUATION: EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. ROOT CAUSE ROOT CAUSE NOT APPLICABLE AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. FINISHED GOODS INVENTORY OF THE WORK ORDERS SHIPPED TO THE CUSTOMER IN THE PAST 2 YEARS HAS BEEN DEPLETED. IT SHOULD BE NOTED THIS PRODUCT IS 100% FUNCTIONALLY LEAK TESTED PRIOR TO PACKAGING. IN ADDITION, THE REPORTED TIP (PART NUMBER UML516) WAS 6 CM IN LENGTH AND ACCORDING TO THE COMPLAINT, THE 6 CM TIP WAS SWITCHED TO AN 8 CM TIP TO FINISH THE CASE. BASED ON NO PRIOR COMPLAINT HISTORY FOR THIS CONDITION AND OTHER INFORMATION LISTED FROM ABOVE, THIS INCIDENT IS CONSIDERED AN ISOLATED INCIDENT. CORRECTIVE ACTIONS: COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO TRAINING REQUIRED AT THIS TIME. *WAS THE COMPLAINT CONFIRMED? NO.

    Description of Event or Problem · 0

    METAL TIP PERFORATED. SWITCHED TO 8CM TIP AND FINISHED CASE FOLLOW-UP: DR. (B)(6). SHARED THAT MID-CASE THEY NOTICED THE METAL TIP PERFORATED THE UTERUS DURING A TLH, DR. (B)(6). THEN REMOVED THE RUMI AND PLACED A 8CM TIP THEN COMPLETED THE CASE. UTERINE MANIPULATOR TIP L (B)(4).

    Description of Event or Problem · 0

    METAL TIP PERFORATED. SWITCHED TO 8CM TIP AND FINISHED CASE FOLLOW-UP: DR. (B)(6). SHARED THAT MID-CASE THEY NOTICED THE METAL TIP PERFORATED THE UTERUS DURING A TLH, DR. (B)(6). THEN REMOVED THE RUMI AND PLACED A 8CM TIP THEN COMPLETED THE CASE. UTERINE MANIPULATOR TIP L (B)(4).

    Description of Event or Problem · 0

    METAL TIP PERFORATED. SWITCHED TO 8CM TIP AND FINISHED CASE FOLLOW-UP: DR. (B)(6). SHARED THAT MID-CASE THEY NOTICED THE METAL TIP PERFORATED THE UTERUS DURING A TLH, DR. (B)(6). THEN REMOVED THE RUMI AND PLACED A 8CM TIP THEN COMPLETED THE CASE. UTERINE MANIPULATOR TIP L (B)(4).

    Description of Event or Problem · 0

    METAL TIP PERFORATED. SWITCHED TO 8CM TIP AND FINISHED CASE. INVOICE#: (B)(6). FOLLOW-UP: DR. SAAD SHARED THAT MID-CASE THEY NOTICED THE METAL TIP PERFORATED THE UTERUS DURING A TLH, DR. (B)(6) THEN REMOVED THE RUMI AND PLACED A 8CM TIP THEN COMPLETED THE CASE. 1216677-2021-00334-1 UTERINE MANIPULATOR TIP L UML516 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1673966 UTERINE MANIPULATOR TIP L UTERINE MANIPULATOR TIP L LKF COOPERSURGICAL, INC. UML516 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other