BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUMI II,BACKLOADABLE

    MDR report key: 11569765 · Received March 25, 2021

    Report

    Report Number
    1216677-2021-00050
    Event Type
    Malfunction
    Date Received
    March 25, 2021
    Date of Event
    January 13, 2021
    Report Date
    January 27, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    LKF
    UDI-DI
    00888937015232
    PMA / PMN Number
    K932115
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INITIATED MANUFACTURER'S INVESTIGATION REVIEW DHR INSPECT RETURNED SAMPLES *ANALYSIS AND FINDINGS DISTR. HISTORY THE COMPLAINT PRODUCT (SN 24872121) WAS MANUFACTURED AT CSI ON 05/31/18 UNDER WORK ORDER 248721. MANUF. RECORD REVIEW DHR - 248721 WAS REVIEWED AND NO NON-CONFORMITY, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECT. REVIEW INCOMING INSPECTION RECORD REVIEW NOT APPLICABLE TO THIS PRODUCT. SERV. HIST. RECORD NO SERVICE HISTORY RECORD FOUND FOR THIS UNIT. HISTORICAL COMPLAINT REVIEW A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITIONS, WHERE THE HANDLE BROKE. PRODUCT RECEIPT THE COMPLAINT UNIT WAS RETURNED 03/31/21. VISUAL EVAL. VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED A BROKEN HANDLE FUNCTIONAL EVAL. COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. DURING INVESTIGATION, THE HANDLE WAS FOUND TO BE BROKEN, WITH THE BREAK GOING THROUGH THE WIRE HOLE ON THE HANDLE. ROOT CAUSE BASED ON THE HISTORICAL COMPLAINTS AND PRIOR ROOT CAUSE INVESTIGATION, IT WAS CONFIRMED FROM TESTS THAT THE FAILURES WERE OCCURRING AT A LEVEL OF FORCE NOT LIKELY TO OCCUR WITH JUST THE ARTICULATION OF THE HANDLE. INSTEAD, IT WAS APPARENT THAT THE LOADS REQUIRED TO BREAK THE HANDLE EXIST WHEN THE KOH EFFICIENT (KE) IS NOT IN THE PROPER POSITION ON THE ARM. WHEN THE KE IS NOT PROPERLY POSITIONED, IT CAN IMPEDE IN THE ROTATION OF THE TIP DRUM, INTRODUCING AN UNDESIRED FORCE ON THE DEVICE WHICH CAN RESULT IN A BROKEN PLASTIC HANDLE BREAK. THE PLASTIC HANDLE DID NOT UNDERGO A RECENT DESIGN OR MATERIAL CHANGE. *CORRECTION AND/OR CORRECTIVE ACTION BASED ON THE INVESTIGATIONS PERFORMED UNDER CAPA 605, IT WAS DETERMINED THAT NO CORRECTIVE ACTION WAS NECESSARY TO ADDRESS THE FAILURE MODE SEEN UNDER THE COMPLAINT UNIT DUE TO A RPN (RISK PRIORITY NUMBER) LOWER THAN 200. UMH650 BROKEN HANDLE COMPLAINTS ARE ENTERED INTO COOPERSURGICAL'S CONTINUOUS IMPROVEMENT PROGRAM (CIP) FOR TRENDING AND MONITORING. THE PRODUCT MET THE REQUIRED RELEASE SPECIFICATIONS PER DHR REVIEW. NO RE-TRAINING REQUIRED. *WAS THE COMPLAINT CONFIRMED? YES

    Description of Event or Problem · 0

    DURING A SURGICAL PROCEDURE (XI ROBOTIC ASSISTED LAPAROSCOPIC SACROCOLPOPEXY WITH MESH WITH SINGLE INCISION SUBURETHRAL SLING) THE GYN SURGEON REQUESTED FOR ADDITIONAL MANIPULATION. THE PEDAL WAS LOOSE AND THE SPRING BROKE FROM THE RUMI HANDLE. THE CERTIFIED SURGICAL TECHNICIAN (CST) WAS THEN REQUESTED TO LOWER THE HANDLE THUS LIFTING THE UTERUS AND THE CST'S ARM GOT CAUGHT THE ALLY AND THE OR TABLE. 1216677-2021-00050-1 RUMI II BACKLOADABLE UMH650 (B)(4)

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 1

    E-COMPLAINT (B)(4). REPORT SUBMITTED BY CSI REP- INCIDENT DETAILS SURROUNDING EVENT DURING A SURGICAL PROCEDURE (XI ROBOTIC ASSISTED LAPAROSCOPIC SACROCOLPOPEXY WITH MESH WITH SINGLE INCISION SUBURETHRAL SLING) THE GYN SURGEON REQUESTED FOR ADDITIONAL MANIPULATION. THE PEDAL WAS LOOSE AND THE SPRING BROKE FROM THE RUMI HANDLE. THE CERTIFIED SURGICAL TECHNICIAN (CST) WAS THEN REQUESTED TO LOWER THE HANDLE THUS LIFTING THE UTERUS AND THE CST'S ARM GOT CAUGHT THE ALLY AND THE OR TABLE. 1216677-2021-00050 RUMI II BACKLOADABLE UMH650 E-COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470125 RUMI II,BACKLOADABLE RUMI II,BACKLOADABLE LKF COOPERSURGICAL, INC. UMH650 N/A 00888937015232

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other