BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUMI II,BACKLOADABLE

    MDR report key: 9108980 · Received September 24, 2019

    Report

    Report Number
    1216677-2019-00265
    Event Type
    Malfunction
    Date Received
    September 24, 2019
    Date of Event
    July 26, 2019
    Report Date
    December 23, 2019
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    LKF
    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

    ANALYSIS AND FINDINGS: (B)(4). WAS THE COMPLAINT CONFIRMED? YES. DISTR. HISTORY: THE COMPLAINT PRODUCT (SN (B)(6) WAS MANUFACTURED AT CSI ON 12/10/18 UNDER WORK ORDER (B)(4). MANUF. RECORD REVIEW: DHR - 261663 WAS REVIEWED AND NO NON-CONFORMITIES, 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 AND A SPLIT HANDLE. FUNCTIONAL EVAL: COMPLAINT UNIT/PRODUCT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. DURING INVESTIGATION, THE WIRE WAS FOUND BROKEN, AND A SMALL CRACK WAS ALSO FOUND ON THE BLUE HANDLE. 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: 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. PREVENTATIVE ACTION ACTIVITY: COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR ANY TRENDS.

    Description of Event or Problem · 0

    CUSTOMER STATED "TIP BROKE OFF OF HANDLE DURING NORMAL USE INTRA-OPERATIVELY E BOX." REF (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE FILED. REFERENCE E-COMPLAINT-E-COMPLAINT (B)(4).

    Description of Event or Problem · 1

    CUSTOMER STATED "TIP BROKE OFF OF HANDLE DURING NORMAL USE INTRA-OPERATIVELY'E BOX." REF E-COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907800 RUMI II,BACKLOADABLE RUMI II,BACKLOADABLE LKF COOPERSURGICAL, INC. UMH650 -

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other