BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UTERINE MANIPULATOR & INJECTOR (PUMI) 4.5MM

    MDR report key: 7042541 · Received November 17, 2017

    Report

    Report Number
    1833117-2017-00007
    Event Type
    Malfunction
    Date Received
    November 17, 2017
    Date of Event
    October 20, 2017
    Report Date
    November 17, 2017
    Manufacturer
    CATHETER RESEARCH, INC.
    Product Code
    LKF
    PMA / PMN Number
    K974357
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS MANUFACTURED IN NOVEMBER 2015 AS PART OF A LOT SIZE OF 1224. IT IS THE FIRST UNIT REPORTED FROM THAT LOT. THE TH3111 IS PART OF A FAMILY OF UTERINE MANIPULATORS. SINCE (B)(4) 2015, CATHETER RESEARCH HAS MANUFACTURED AND SOLD APPROXIMATELY (B)(4) UNITS AND HAS REPORTED BREAKAGE OF A TOTAL OF 6, INCLUDING THE UNIT IN THIS REPORT, TO FDA. MANUFACTURE DATES OF THE UNITS THAT EXPERIENCED THE BREAKAGE: (B)(4) 2015, (B)(4) 2015, (B)(4) 2016, (B)(4) 2016, (B)(4) 2016, (B)(4) 2017. THERE DOES NOT APPEAR TO BE ANY PATTERN TO THE MANUFACTURING DATES. THE "SERIOUS INJURY" FOR SOME OF THESE EVENTS HAS BEEN THE REQUIREMENT TO REMOVE THE DEVICE AFTER THE PROCEDURE. THE IFU INSTRUCTS THE USER TO CHECK FOR BROKEN PIECES BEFORE FINISHING THE PROCEDURE. IN THIS CASE, THE USER APPEARS TO HAVE FOLLOWED THE IFU, BUT REPORTED THE BREAKAGE TO LOCAL REGULATORY AUTHORITIES.

    Description of Event or Problem · 1

    (B)(6) RECEIVED THE FOLLOWING UF REPORT FROM ITS DIRECT CUSTOMER, PURPLE SURGICAL, THE INITIAL REPORTER DESCRIBED LATER. THE (B)(6) HOSPITAL IN (B)(6) REPORTED THIS ISSUE WITH THE UTERINE MANIPULATOR, TH3111 : DESCRIBE THE FAULT WITH THE PRODUCT DEVICE BROKE INTO TWO PARTS DURING USE IN A LAPAROSCOPIC GYNAE PROCEDURE. INFLATED BALLOON WAS LEFT INSIDE THE PATIENT WHICH WAS SAFELY RETRIEVED BY CONSULTANT GYNAE SURGEON WHAT PROCEDURE WAS BEING CARRIED OUT? LAP GYNAE PROCEDURE . WAS THERE ANY PATIENT HARM? NO INJURY CAUSED. (B)(6) COMMENT - ALTHOUGH NO INJURY OCCURRED WITH THIS INCIDENT, OTHER INCIDENTS OF BREAKAGE HAVE RESULTED IN A REQUIREMENT FOR MEDICAL INTERVENTION TO REMOVE BROKEN PIECES, CONSTITUTING "SERIOUS INJURY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820223 UTERINE MANIPULATOR & INJECTOR (PUMI) 4.5MM CANNULA, MANIPULATOR/INJECTOR, UTERINE LKF CATHETER RESEARCH, INC. TH3111 M954

    Patients

    Seq Age Sex Outcome Treatment
    1