BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUMI II,BACKLOADABLE

    MDR report key: 14394632 · Received May 13, 2022

    Report

    Report Number
    1216677-2022-00148
    Event Type
    Malfunction
    Date Received
    May 13, 2022
    Date of Event
    March 28, 2022
    Report Date
    May 13, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    LKF
    PMA / PMN Number
    K932115
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL, INC. IS CURRENLTY INVESTIGATING THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: X-INITIATED MANUFACTURER'S INVESTIGATION: X-NO SAMPLE RETURNED; X-REVIEW DHR. ANALYSIS AND FINDINGS DISTR. HISTORY THE COMPLAINT PRODUCT (SN (B)(6)) WAS MANUFACTURED AT CSI ON 01/19/22 UNDER WORK ORDER (B)(4). MANUF. RECORD REVIEW DHR - (B)(4) 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 DID SHOW COMPLAINTS SIMILAR TO THE COMPLAINT CONDITION. HOWEVER, IT IS UNKNOW HOW THE COMPLAINT UNIT WAS BROKEN AS IT HAS NOT BEEN RETURNED. 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 BREAKING 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. 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. PREVENTATIVE ACTION ACTIVITY: COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Description of Event or Problem · 0

    INCIDENT DETAILS SURROUNDING EVENT WE JUST RECEIVED THE PRODUCT FROM COOPER SURGICAL, WE DELIVERED TO A HOSPITAL THAT BOUGHT 2 RUMI AND 2 KC-SIZER. THE BRAND NEW RUMI II WAS USED IN A PATIENT, THEY PERFORMED THE SURGERY AND ALMOST AN THE END WHEN THEY PERFORMED THE COLPOTOMY, THE RUMI BROKE APART IN PIECES THIS DID NOT ALLOW THE DOCTOR TO CONTINUE WITH THE SURGERY, THE RUMI SEPARATED INTO PIECES, BUT LUCKILY NO PIECE OF THE RAILS OR THE HANDLE REMAINED INSIDE THE PATIENT. THEY FINISHED THE PROCEDURE VAGINAL. 1216677-2022-00148 RUMI II BACKLOADABLE UMH650 E-COMPLAINT-(B)(4).

    Description of Event or Problem · 0

    INCIDENT DETAILS SURROUNDING EVENT WE JUST RECEIVED THE PRODUCT FROM COOPER SURGICAL, WE DELIVERED TO A HOSPITAL THAT BOUGHT 2 RUMI AND 2 KC-SIZER. THE BRAND NEW RUMI II WAS USED IN A PATIENT, THEY PERFORMED THE SURGERY AND ALMOST AN THE END WHEN THEY PERFORMED THE COLPOTOMY, THE RUMI BROKE APART IN PIECES THIS DID NOT ALLOW THE DOCTOR TO CONTINUE WITH THE SURGERY, THE RUMI SEPARATED INTO PIECES, BUT LUCKILY NO PIECE OF THE RAILS OR THE HANDLE REMAINED INSIDE THE PATIENT. THEY FINISHED THE PROCEDURE VAGINAL. 1216677-2022-00148 RUMI II BACKLOADABLE UMH650 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2309899 RUMI II,BACKLOADABLE RUMI II,BACKLOADABLE LKF COOPERSURGICAL, INC. UMH650 -

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Congenital Anomaly| O