BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE-USE BIOPSY FORCEPS

    MDR report key: 7628759 · Received June 22, 2018

    Report

    Report Number
    3004837686-2018-00002
    Event Type
    Malfunction
    Date Received
    June 22, 2018
    Date of Event
    June 10, 2017
    Report Date
    June 22, 2018
    Manufacturer
    MICRO-TECH(NANJING) CO.,LTD
    Product Code
    KGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SHORT-TERM CORRECTIVE ACTIONS: THE TENSION TUBE DEFECT HAS BEEN MADE KNOWN TO THE SUPPLIER, THE SUPPLIER HAS DESIGNED A NEW FIXTURE TO REMOVE UNQUALIFIED TENSION TUBES IN THEIR PROCESS.-- (B)(4) (COMPLETED). TRAIN OPERATORS TO CHECK WHETHER THE TENSION TUBE CAN BE ASSEMBLED, AND IF NOT, THE DEFECTIVE PRODUCT SHOULD BE REMOVED IMMEDIATELY. ON 2018-05-30 (B)(4) (COMPLETED) PERMANENT CORRECTIVE ACTIONS: IN ORDER TO BETTER IMPROVE CUSTOMER EXPERIENCE, AND FOOLPROOF DESIGN, CHANGE THE DESIGN OF THE TENSION TUBE TO MAKE THE T-SHAPED TENSION TUBE. IF THE LENGTH OF THE TENSION TUBE EXCEEDS THE TOLERANCE, THE TENSION TUBE WOULD NOT FIT INTO THE SLIDER AFTER THE TENSION TUBE IS ASSEMBLED WITH THE TENSION BLOCK. THIS REDESIGN REDUCES THE CRITICALITY OF THE DIMENSION. THE DESIGN CHANGE INTRODUCES NO ADDITIONAL CONTACT POINTS AND NO NEW RISKS. INITIAL TENSILE TESTING OF ALL (B)(4) SAMPLES MADE WAS GREATER THAN 100N AND RESULTING IN A CPK OF 2.95, WHICH MET THE REQUIREMENTS. (B)(4) 2018-07-30 (TO BE COMPLETED).

    Description of Event or Problem · 1

    MICRO-TECH (NANJING) CO.,LTD. RECEIVED A COMPLAINT ON ITS FORCEPS FROM (B)(6) ON MARCH 3, 2018. IT WAS REPORTED BY THE DOCTOR THAT THE PRODUCT DID NOT CLOSE DURING CASE, AND IT WAS NECESSARY TO WITHDRAWAL THE DEVICE IN THE OPEN POSITION. THE ONLY WAS TO CLOSE IT WAS TO MANUALLY FORCE IT CLOSED. THIS SUBMISSION DOES NOT, IN OUR OPINION, POSE ANY SERIOUS RISK TO A PATIENT OR USER, BUT WE ARE CONSIDERING IT AN MDR BASED ON IT BEING AN ADVERSE EVENT THAT NEEDS TO BE REPORTED TO (B)(6). MICRO-TECH COMMUNICATED WITH (B)(6) FOR THE SAMPLES TO BE SENT BACK. MICRO-TECH (NANJING) CO.,LTD. RECEIVED THE COMPLAINT SAMPLE (QTY:1) ON MAY 23, 2018. MICRO-TECH (NANJING) CO.,LTD IS REPORTING THIS ADVERSE EVENT TO THE FDA, AS THIS PRODUCT IS ALSO SOLD IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473785 SINGLE-USE BIOPSY FORCEPS SINGLE-USE BIOPSY FORCEPS KGE MICRO-TECH(NANJING) CO.,LTD NBF03-11023230 B170216001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other