BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUMI II,BACKLOADABLE

    MDR report key: 10935565 · Received December 2, 2020

    Report

    Report Number
    1216677-2020-00284
    Event Type
    Malfunction
    Date Received
    December 2, 2020
    Date of Event
    October 15, 2020
    Report Date
    December 2, 2020
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    LKF
    PMA / PMN Number
    K932115
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION X-INITIATED MANUFACTURER'S INVESTIGATION X-REVIEW DHR. X-INSPECT RETURNED SAMPLES. ANALYSIS AND FINDINGS E-COMPLAINT (B)(4). WAS THE COMPLAINT CONFIRMED? YES. DISTR. HISTORY THE COMPLAINT PRODUCT (SN (B)(6)) WAS MANUFACTURED AT CSI ON 07/23/19 UNDER WORK ORDER (B)(4). MANUF. RECORD REVIEW DHR - 273450 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 TIP CAME OFF DUE TO WIRE BREAK. PRODUCT RECEIPT THE COMPLAINT UNIT WAS RETURNED. VISUAL EVAL. VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED A BROKEN WIRE. FUNCTIONAL EVAL. COMPLAINT UNIT/PRODUCT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. DURING INVESTIGATION, THE WIRE WAS FOUND BROKEN. 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 PLASTIC HANDLE OR WIRE BREAK. THE PLASTIC HANDLE, AND WIRES DID NOT UNDERGO A RECENT DESIGN OR MATERIAL CHANGE. *CORRECTION AND/OR CORRECTIVE ACTION / *PREVENTATIVE ACTION ACTIVITY 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 WIRE AND 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.

    Description of Event or Problem · 0

    REPORT SUBMITTED BY CSI REP- INCIDENT REPORT: BOTH HANDLES BROKE DURING A TLH WHILE DOC WAS TRYING TO ANTI-VERT UTERUS. THEY OCCURRED APPROXIMATELY 3 WEEKS APART. ADDITIONAL COMPLAINT INITIATED FOR SECOND RUMI. 11.13.2020 . NO ADDITIONAL MEDICAL ATTENTION WAS NEEDED. IT WAS VERY DIFFICULT TO MANIPULATE UTERUS DUE TO THE LACK OF ARTICULATION IN THE TIP. COLPOTOMY WAS DIFFICULT ON THE POSTERIOR SIDE AND HAD TO ACTUALLY HOLD UTERUS VIA MARYLAND FORCEPS VIA TROCAR. NO FRAGMENTS, ADDED AT LEAST 30 MINS ON TO PROCEDURE. 1216677-2020-00284 RUMI II BACKLOADABLE UMH650 E-COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL, INC. IS CURRENLTY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 1

    REPORT SUBMITTED BY CSI REP- INCIDENT REPORT: BOTH HANDLES BROKE DURING A TLH WHILE DOC WAS TRYING TO ANTI-VERT UTERUS. THEY OCCURRED APPROXIMATELY 3 WEEKS APART. ADDITIONAL COMPLAINT INITIATED FOR SECOND RUMI. (B)(6) 2020. NO ADDITIONAL MEDICAL ATTENTION WAS NEEDED. IT WAS VERY DIFFICULT TO MANIPULATE UTERUS DUE TO THE LACK OF ARTICULATION IN THE TIP. COLPOTOMY WAS DIFFICULT ON THE POSTERIOR SIDE AND HAD TO ACTUALLY HOLD UTERUS VIA MARYLAND FORCEPS VIA TROCAR. NO FRAGMENTS, ADDED AT LEAST 30 MINS ON TO PROCEDURE. RUMI II BACKLOADABLE UMH650 E-COMPLAINT(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1402297 RUMI II,BACKLOADABLE RUMI II,BACKLOADABLE LKF COOPERSURGICAL, INC. UMH650 -

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other