BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UTERINE MANIPULATOR TIP W

    MDR report key: 9993097 · Received April 23, 2020

    Report

    Report Number
    1216677-2020-00096
    Event Type
    Malfunction
    Date Received
    April 23, 2020
    Date of Event
    March 28, 2020
    Report Date
    February 6, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    LKF
    UDI-DI
    00888937001440
    PMA / PMN Number
    K932115
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: INITIATED MANUFACTURER'S INVESTIGATION: NO SAMPLE RETURNED, REVIEW DHR. DISTRIBUTION HISTORY THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI ON 03/28/19 UNDER WORK ORDER (B)(4). MANUFACTURING RECORD REVIEW: (B)(4) WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: INCOMING INSPECTION RECORD REVIEW NOT APPLICABLE TO THIS PRODUCT. SERVICE HISTORY RECORD: SERVICE HISTORY NOT APPLICABLE FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT: THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. VISUAL EVALUATION: CONFIRMATION OF THE REPORTED BALLOON RUPTURE EVENT WAS OBTAINED THROUGH PROVIDED ATTACHED PHOTOS. 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: NO DEFINITIVE ROOT CAUSE FOR THIS ISSUE COULD BE RELIABLY DETERMINED AT THIS TIME. CORRECTIVE ACTIONS: CORRECTIVE ACTION IS NOT APPLICABLE AT THIS TIME DUE TO THE ABSENCE OF THE AFFECTED SAMPLE FOR INVESTIGATIVE ANALYSIS. NO FURTHER TRAINING REQUIRED AT THIS TIME; COMPLAINT WILL BE MONITORED FOR TRENDING. WAS THE COMPLAINT CONFIRMED? YES.

    Description of Event or Problem · 0

    REPORT STATED: "BALLOON EXPLODED WHEN SURGEON INFLATED WITH NORMAL SALINE. DURING LAPAROSCOPIC MYOMECTOMY + OVARIAN CYSTECTOMY + HYSTEROSCOPY. CHECKED FOR THE COMPLETENESS OF THE BALLOON AND SEARCHED - NO FOREIGN BODY REMAINED IN PATIENT BODY". 1216677-2020-00096-1, UMW676 UTERINE MANIPULATOR TIP W E-COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    REF. (B)(4). COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION.

    Description of Event or Problem · 1

    REPORT STATED "WE GET A CALL FROM PREVIOUS CLIENT (ANCHOR) TO INFO US THAT THE RUMI WAS BROKEN AFTER SURGERY RECENTLY". 04.09.2020- REPORT UPDATE- BALLOON EXPLODED WHEN SURGEON INFLATED WITH NORMAL SALINE. DURING LAPAROSCOPIC MYOMECTOMY + OVARIAN CYSTECTOMY + HYSTEROSCOPY. CHECKED FOR THE COMPLETENESS OF THE BALLOON AND SEARCHED - NO FOREIGN BODY REMAINED IN PATIENT BODY. REFERENCE E-COMPLAINT NUMBER : (B)(4). UTERINE MANIPULATOR TIP W UMW676 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456084 UTERINE MANIPULATOR TIP W UTERINE MANIPULATOR TIP W LKF COOPERSURGICAL, INC. UMW676 260460 00888937001440

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other