BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUMI II,BACKLOADABLE

    MDR report key: 13025283 · Received December 17, 2021

    Report

    Report Number
    1216677-2021-00290
    Event Type
    Malfunction
    Date Received
    December 17, 2021
    Date of Event
    October 25, 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
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: NO SAMPLE RETURNED . ANALYSIS AND FINDINGS DISTR. HISTORY A DISTRIBUTION HISTORY REVIEW FOR THE PRODUCT COULD NOT BE PERFORMED BECAUSE A SERIAL # WAS NOT PROVIDED. MANUF. RECORD REVIEW A DHR REVIEW COULD NOT BE PERFORMED BECAUSE A LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. INCOMING INSPECT. REVIEW INCOMING INSPECTION RECORD REVIEW NOT APPLICABLE TO THIS PRODUCT. SERV. HIST. RECORD SERVICE HISTORY RECORD COULD NOT BE REVIEWED BECAUSE SERIAL # WAS NOT PROVIDED. HISTORICAL COMPLAINT REVIEW A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITIONS, WHERE THE WIRE BROKE. PRODUCT RECEIPT THE COMPLAINT UNIT HAS NOT BEEN RETURNED TO COOPERSURGICAL. VISUAL EVAL. VISUAL EXAMINATION OF THE COMPLAINT UNIT WAS NOT POSSIBLE AS IT WAS NOT RETURNED. FUNCTIONAL EVAL. EVALUATION OF THE COMPLAINT UNIT COULD NOT BE COMPLETED AS THE COMPLAINT UNIT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE UNIT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. ROOT CAUSE ROOT CAUSE NOT APPLICABLE AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. COMPLAINT HISTORY SHOWS OTHER INSTANCES WHERE THE WIRE BROKE. IN THOSE CASES, 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. 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 LOT NUMBER NOR PRODUCT WAS 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

    RUMI II HANDLE BROKE WHILE BEING USED FOR UTERINE MANIPULATION. ALL PIECES REMOVED FROM PATIENT. INSTRUMENT TAKEN OFF FIELD IMMEDIATELY AND REPLACED WITH AN ALTERNATE DISPOSABLE UTERINE MANIPULATOR. INSTRUMENT BROUGHT BACK TO DECONTAMINATION AT END OF CASE WITH NOTE "BROKE" AND DEVICE IN PIECES. RUMI II BACKLOADABLE UMH650 (B)(4).

    Description of Event or Problem · 0

    PER MEDWATCH RUMI II HANDLE BROKE WHILE BEING USED FOR UTERINE MANIPULATION. ALL PIECES REMOVED FROM PATIENT. INSTRUMENT TAKEN OFF FIELD IMMEDIATELY AND REPLACED WITH AN ALTERNATE DISPOSABLE UTERINE MANIPULATOR. INSTRUMENT BROUGHT BACK TO DECONTAMINATION AT END OF CASE WITH NOTE "BROKE" AND DEVICE IN PIECES. UF (B)(4). 1216677-2021-00290 RUMI II BACKLOADABLE UMH650 E-COMPLAINT-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1921848 RUMI II,BACKLOADABLE RUMI II,BACKLOADABLE LKF COOPERSURGICAL, INC. UMH650 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| L