BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UTERINE MANIPULATOR TIP L

    MDR report key: 15347763 · Received September 2, 2022

    Report

    Report Number
    1216677-2022-00249
    Event Type
    Malfunction
    Date Received
    September 2, 2022
    Date of Event
    August 17, 2022
    Report Date
    November 11, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    LKF
    PMA / PMN Number
    K932115
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL , INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION X-REVIEW DHR X-INSPECT RETURNED SAMPLES *ANALYSIS AND FINDINGS COMPLAINT 2022-08-0000394 DISTRIBUTION HISTORY: THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI ON 18-JUN-2021 UNDER WORK ORDER 305954 AND SOLD ON 22-SEP-2021. MANUFACTURING RECORD REVIEW: DHR-305954 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: NO SERVICE HISTORY RECORD FOUND FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT: THE COMPLAINT PRODUCT WAS RETURNED OPENED ON 14-SEP-2022. THE LOT NUMBER OF THE RETURNED PRODUCT COULD NOT BE DETERMINED. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT PRODUCT REVEALED PHYSICAL DAMAGE. THE STAINLESS STEEL ROD WAS PROTRUDING FROM THE SIDE OF THE DISTAL TIP. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND TO FUNCTION PROPERLY. THE BALLOON WAS INFLATED AND HELD AIR (SEE ATTACHED PICTURE) AND WATER WAS ABLE TO BE INJECTED THROUGH THE DISTAL TIP OPENING. ROOT CAUSE: WHILE NO DEFINITIVE ROOT CAUSE COULD BE RELIABLY DETERMINED, THE MOST LIKELY ROOT CAUSE WAS CUSTOMER MISUSE. EACH UNIT OF EVERY LOT PRODUCED IS 100% TESTED AND VISUALLY INSPECTED TO MEET THE RELEASE CRITERIA. *CORRECTION AND/OR CORRECTIVE ACTION COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. *PREVENTATIVE ACTION ACTIVITY COOPERSURGICAL WILL CONTINUE TO TREND THIS COMPLAINT CONDITION.

    Description of Event or Problem · 0

    "DR. SAID PLACED THE RUMI TIP IN THE PATIENT. PATIENT HAD FIBROIDS IN THE UTERINE CAVITY. RUMI II WAS ON UTILIZED ON ALLY UPS. DURING THE CASE, THE METAL OF THE RUMI TIP WAS SEEN IN THE ABDOMEN. RUMI II WAS EXTRACTED IMMEDIATELY ONCE NOTICED. VERY LITTLE BLEEDING OCCURRED AT THE SITE IN THE ABDOMEN." DID THE INCIDENT OCCUR BEFORE, DURING, OR AFTER A PROCEDURE? DURING. PATIENT, GAMETE, EMBRYO, OR END USER INVOLVEMENT? YES. ANY PATIENT INJURY OR IMPACT TO THE GAMETE OR EMBRYO? YES. MEDICAL OR PROCEDURAL INTERVENTION? NO. PATIENT IS FINE. UTERINE MANIPULATOR TIP L UML516. E-COMPLAINT(B)(4).

    Description of Event or Problem · 0

    INCIDENT DETAILS SURROUNDING EVENT. "DR. SAID PLACED THE RUMI TIP IN THE PATIENT. PATIENT HAD FIBROIDS IN THE UTERINE CAVITY. RUMI II WAS ON UTILIZED ON ALLY UPS. DURING THE CASE, THE METAL OF THE RUMI TIP WAS SEEN IN THE ABDOMEN. RUMI II WAS EXTRACTED IMMEDIATELY ONCE NOTICED. VERY LITTLE BLEEDING OCCURRED AT THE SITE IN THE ABDOMEN." DID THE INCIDENT OCCUR BEFORE, DURING, OR AFTER A PROCEDURE? DURING. PATIENT, GAMETE, EMBRYO, OR END USER INVOLVEMENT? YES. ANY PATIENT INJURY OR IMPACT TO THE GAMETE OR EMBRYO? YES. MEDICAL OR PROCEDURAL INTERVENTION? NO. PATIENT IS FINE. 1216677-2022-00249 UTERINE MANIPULATOR TIP L UML516 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1808722 UTERINE MANIPULATOR TIP L UTERINE MANIPULATOR TIP L LKF COOPERSURGICAL, INC. UML516 305954

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other