BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREC BRONCH ALL 1.8 115

    MDR report key: 9222902 · Received October 23, 2019

    Report

    Report Number
    3004837686-2019-00006
    Event Type
    Malfunction
    Date Received
    October 23, 2019
    Date of Event
    June 6, 2019
    Report Date
    October 23, 2019
    Manufacturer
    MICRO-TECH(NANJING) CO.,LTD
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT PRODUCT WAS NOT RETURNED, THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCTS RELEASED FOR DISTRIBUTION WERE FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT AND FOUND NO ABNORMALITIES THAT WOULD CONTRIBUTE TO THIS ISSUE. THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE USER WITH INFORMATION ABOUT THE PROPER USE OF THE MEDICAL DEVICE. THE INSTRUMENT SHALL BE INSPECTED AND/OR TESTED BEFORE USE TO ENSURE THAT THE DEVICE OPERATES AS EXPECTED AND TO CONFIRM THAT THE SPECIFICATIONS OF THE DEVICE ARE COMPATIBLE WITH THE ENDOSCOPE. OPEN AND CLOSE THE JAWS SEVERAL TIMES USING THE HANDLE TO CONFIRM SMOOTH MOVEMENT. DO NOT USE THE FORCEPS IF IT IS DAMAGED. THE IFU ADVISES THE USER THAT : -WHEN ADVANCING FORCEPS THROUGH ENDOSCOPE, CARE SHOULD BE TAKEN THAT, IF RESISTANCE IS MET, THE ENDOSCOPE TIP SHOULD BE REPOSITIONED TO ALLOW SMOOTH PASSAGE OF THE BIOPSY FORCEPS. -BE CERTAIN THAT THE FORCEPS ARE IN THE CLOSED POSITION PRIOR TO ADVANCING THE FORCEPS INTO THE ENDOSCOPE, AND MAINTAIN THIS CLOSED POSITION WHILE MOVING THROUGH THE WORKING CHANNEL OF THE ENDOSCOPE. -DO NOT FORCE THE FORCEPS IF THEY DO NOT PASS SMOOTHLY THROUGH THE ENDOSCOPE, AS THIS MAY DAMAGE BOTH THE FORCEPS AND THE INSTRUMENT CHANNEL OF THE ENDOSCOPE. -DO NOT APPLY EXCESSIVE FORCE WHEN OPENING AND CLOSING THE FORCEPS. - WHEN REMOVING THE FORCEPS, WITH THE JAWS CLOSED, SLOWLY WITHDRAW THE FORCEPS FROM THE ENDOSCOPE. BE SURE TO LOWER THE SCOPE ELEVATOR BEFORE WITHDRAWING THE FORCEPS FROM THE SCOPE. SINCE THE COMPLAINT PRODUCT WAS NOT AVAILABLE, BASED ON THE INFORMATION RECEIVED SO FAR, WE CAN'T MAKE AN ACCURATE ANALYSIS AND FIND THE ROOT CAUSE FOR THE TIME BEING. WE WILL CONTINUE TO PAY MORE ATTENTION TO THIS ISSUE TO ENSURE THE PATIENT SAFETY.

    Description of Event or Problem · 1

    ON (B)(6) 2019, WE SEARCHED THE FDA MAUDE DATABASE AND FOUND AN EVENT CONCERNING #1000507 BIOPSY FORCEPS WHICH WAS REPORTED BY CONMED. THE EVENT(REPORT NUMBER (B)(4) IS DESCRIBED AS FOLLOWS: THE CUSTOMER REPORTED THAT 100507 DEVICE WAS USING DURING A FIBRO BRONCHIAL ENDOSCOPY PROCEDURE ON (B)(6) 2019. WHEN REMOVING THE DEVICE, IT WOULD NOT COME OUT OF THE SCOPE. THE DEVICE HAD TO BE CUT IN ORDER TO REMOVE IT FROM THE SCOPE. THERE WAS NO REPORT OF FRAGMENTATION BEING REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WAS NO REPORT OF PATIENT OR USER INJURY. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE. MICRO-TECH INITIATED AN INVESTIGATION BASED ON THESE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1025310 PREC BRONCH ALL 1.8 115 FORCEPS, BIOPSY, NON-ELECTRIC FCL MICRO-TECH(NANJING) CO.,LTD M181215002

    Patients

    Seq Age Sex Outcome Treatment
    1 Other