BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUMI II,BACKLOADABLE

    MDR report key: 12961428 · Received December 8, 2021

    Report

    Report Number
    1216677-2021-00273
    Event Type
    Malfunction
    Date Received
    December 8, 2021
    Date of Event
    April 1, 2021
    Report Date
    April 7, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    LKF
    PMA / PMN Number
    K932115
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: INITIATED MANUFACTURER'S INVESTIGATION. NO SAMPLE RETURNED. REVIEW DHR. ANALYSIS AND FINDINGS: DISTR. HISTORY: THE COMPLAINT PRODUCT (SN (B)(6)) WAS MANUFACTURED AT CSI ON 04/22/19 UNDER WORK ORDER (B)(4). MANUF. RECORD REVIEW: DHR - 269276 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 THIS UNIT WAS RETURNED ON 05/04/18 FOR BROKEN HANDLE. PRODUCT WAS REPAIRED AND SHIPPED BACK TO CUSTOMER. HISTORICAL COMPLAINT REVIEW A REVIEW OF THE 2-YEAR COMPLAINT HISTORY DID SHOW COMPLAINTS SIMILAR IN TERMS OF THE PART BECOMING LOOSE DUE TO HANDLE BREAK. IT IS UNKNOWN IF THE HANDLE BROKE IN THIS PRODUCT, BASED ON THE INFORMATION GIVEN. PRODUCT RECEIPT THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. VISUAL EVAL. VISUAL EXAMINATION OF THE COMPLAINT UNIT WAS NOT POSSIBLE AS PRODUCT HAS NOT BEEN RETURNED. FUNCTIONAL EVAL. FUNCTIONAL EVALUATION WAS NOT POSSIBLE AS PRODUCT HAS NOT YET BEEN RETURNED. ROOT CAUSE ALTHOUGH THE PRODUCT WAS NOT RETURNED, BASED ON THE HISTORICAL COMPLAINTS AND PRIOR ROOT CAUSE INVESTIGATION, THE PART BECOMING LOOSE MAY BE DUE TO A BROKEN HANDLE. IN THOSE COMPLAINTS, 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. CORRECTIVE ACTIONS: 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 CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 0

    PER MEDWATCH UF/IMPORTER REPORT # (B)(4). B5 EVENT DESCRIPTION: "THE RUMI II HANDLE HAS BROKEN AT THE HANDLE CAUSING A DELAY ON OUR CASE OF 1 HOUR AND 30 MINUTES. THE INSTRUMENT WAS OPENED AFTER THE STERILIZATION PROCESS AND FOUND TO BE BROKEN. I AM SURE WHERE THE ITEM WAS BROKEN BUT CANNOT USE IT AND WE MUST REPLACE IT WITH A NEW INSTRUMENT. " USER FACILITY : (B)(6) 1216677-2021-00273-1 RUMI II BACKLOADABLE UMH650 (B)(4).

    Description of Event or Problem · 0

    PER MEDWATCH UF/IMPORTER REPORT # (B)(4). EVENT DESCRIPTION: "THE RUMI II HANDLE HAS BROKEN AT THE HANDLE CAUSING A DELAY ON OUR CASE OF 1 HOUR AND 30 MINUTES. THE INSTRUMENT WAS OPENED AFTER THE STERILIZATION PROCESS AND FOUND TO BE BROKEN. I AM SURE WHERE THE ITEM WAS BROKEN BUT CANNOT USE IT AND WE MUST REPLACE IT WITH A NEW INSTRUMENT. " USER FACILITY : (B)(6). RUMI II BACKLOADABLE UMH650 E-COMPLAINT- (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1856200 RUMI II,BACKLOADABLE RUMI II,BACKLOADABLE LKF COOPERSURGICAL, INC. UMH650 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other