BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUMI II,BACKLOADABLE

    MDR report key: 16402625 · Received February 20, 2023

    Report

    Report Number
    1216677-2023-00029
    Event Type
    Malfunction
    Date Received
    February 20, 2023
    Date of Event
    December 28, 2022
    Report Date
    April 20, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    LKF
    UDI-DI
    00888937015232
    PMA / PMN Number
    K932115
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION NO SAMPLE RETURNED REVIEW DHR. ANALYSIS AND FINDINGS DISTR. HISTORY THE COMPLAINT PRODUCT (SN (B)(6)) WAS MANUFACTURED AT CSI ON 07/20/21 UNDER WORK ORDER (B)(4). MANUF. RECORD REVIEW DHR - 307499 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 PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. VISUAL EVAL. EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. WHILE PHOTOS WERE SUBMITTED WITH THE COMPLAINT, THEY COULD NOT BE ACCESSED. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. FUNCTIONAL EVAL. FUNCTIONAL EVALUATION WAS NOT POSSIBLE AS PRODUCT HAS NOT YET BEEN RETURNED. ROOT CAUSE ALTHOUGH THE PRODUCT WAS NOT RETURNED, THIS COMPLAINT CONDITION IS SIMILAR TO PREVIOUS COMPLAINT INSTANCES. BASED ON THESE 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. THE PLASTIC HANDLE DID NOT UNDERGO A RECENT DESIGN OR MATERIAL CHANGE. SHOULD COMPLAINT UNIT BE RETURNED IN THE FUTURE, ADDITIONAL INFORMATION WILL BE ADDED TO COMPLAINT FILE. CORRECTION AND/OR CORRECTIVE ACTION COOPERSURGICAL WILL CONTINUE TO TREND THIS COMPLAINT CONDITION. NO FURTHER CORRECTIVE ACTION IS REQUIRED AT THIS TIME, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. PRODUCT WAS NOT RETURNED FOR EVALUATION. WAS THE COMPLAINT CONFIRMED? NO.

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL, INC. IS CURRENLTY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 0

    AFTER PLACING THE RUMI W/ATTACHMENT IN PATIENT, THE HANDLE FELL APART AND THE MISSING PART HAD TO BE RETRIEVED FROM PATIENT. RUMI II BACKLOADABLE UMH650 E-COMPLAINT (B)(4).

    Description of Event or Problem · 0

    PER DETAILS REPORTED ON (B)(4). "AFTER PLACING THE RUMI W/ATTACHMENT IN PATIENT, THE HANDLE FELL APART AND THE MISSING PART HAD TO BE RETRIEVED FROM PATIENT. I AM NOT SURE WHEN THIS PARTICULAR HANDLE WAS PURCHASED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1228597 RUMI II,BACKLOADABLE RUMI II,BACKLOADABLE LKF COOPERSURGICAL, INC. UMH650 30749929 00888937015232

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| C