BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROFORMA HF 4.5 CANN CURVED 5/BX

    MDR report key: 12372037 · Received August 26, 2021

    Report

    Report Number
    1320894-2021-00342
    Event Type
    Malfunction
    Date Received
    August 26, 2021
    Date of Event
    July 28, 2021
    Report Date
    August 24, 2021
    Manufacturer
    CONMED UTICA
    Product Code
    DSA
    PMA / PMN Number
    K050777
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THE CUSTOMER'S REPORTED EVENT FINDS IT TO BE CONFIRMED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION, BUT PHOTOGRAPHIC EVIDENCE HAS BEEN PROVIDED. THE IMAGE EXHIBITS THE REPORTED CLAIM HOWEVER A ROOT CAUSE CANNOT BE ESTABLISHED. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED AND FOUND NO ABNORMALITIES THAT WOULD CONTRIBUTE TO THIS ISSUE. A TWO-YEAR LOT HISTORY REVIEW WAS CONDUCTED AND FOUND NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT NUMBER. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 2 COMPLAINTS, REGARDING 2 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME (B)(4) DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED FOR THIS REPORTED FAILURE, THE RATE OF FAILURE WOULD BE (B)(4). THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE USER WITH INFORMATION REGARDING PROPER CARE AND USE OF THIS DEVICE. ALSO PER THE IFU THE USER IS ADVISED THAT ¿PRIOR TO USE, CONFIRM CANNULA PERFORMANCE BY FLUSHING WITH STERILE SALINE. PRIOR TO INSERTION INTO THE WORKING CHANNEL OF THE DUODENOSCOPE, FLUSH THE CANNULA WITH CONTRAST MEDIUM TO REMOVE ALL AIR. INSERT THE CANNULA INTO THE WORKING CHANNEL OF THE DUODENOSCOPE AND ADVANCE USING SHORT, DELIBERATE 2-3 CM MOVEMENTS TO PREVENT KINKING OF THE CATHETER. NOTE: DURING INSERTION, A BLACK MARKER BAND WILL APPROACH THE ENTRANCE OF THE WORKING CHANNEL. THIS INDICATES THAT THE DISTAL TIP OF THE CANNULA WILL START EXITING THE DUODENOSCOPE. THE PROFORMA HF 4.5 CANNULA IS DESIGNED TO BE USED WITH ENDOSCOPES WITH WORKING CHANNELS OF 2.8MM OR LARGER. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    THE FACILITY REPORTED ISSUES WITH THE PROFORMA HF 4.5 CANNULA CURVED, ITEM # 050907, LOT 202104261, THAT (B)(6), EXPERIENCED ON (B)(6) 2021. INFORMATION RECEIVED ONLY INDICATED ¿A PIECE OF METAL CAME OFF THE TIP OF THE PROFORMA CATHETER, DOCTOR HAD TO RETRIEVE IT OUT OF THE DUODENUM¿. IT IS NOTED THERE WAS NO IMPACT OR INJURY TO THE PATIENT. ADDITIONAL INFORMATION AND PICTURES WERE RECEIVED FROM REPORTER. THE ISSUE HAPPENED DURING AN ERCP. THE METAL PIECE SURROUNDING TIP OF PROFORMA CATHETER CAME LOOSE. IT WAS NOTED AFTER CANNULATION OF COMMON BILE DUCT TO BE LOOSE BUT STILL AROUND THE CATHETER, THE METAL PIECE CAME OFF INTO THE DUODENUM DURING INSTRUMENT EXCHANGE AND WAS RETRIEVED. A GUIDE WIRE (UNKNOWN DETAILS) WAS INSIDE PROFORMA CATHETER WHEN ISSUE OCCURRED. THE CANNULA HAD BEEN IN USE ESTIMATED 10-15 MINUTES. IT WAS CONFIRMED THERE WAS NO INJURY TO PATIENT. ALL PIECES REMOVED. INSTRUMENT EXCHANGED, PROCEDURE COMPLETED AND METAL PIECE SUCCESSFULLY REMOVED THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272530 PROFORMA HF 4.5 CANN CURVED 5/BX CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) DSA CONMED UTICA 202104261

    Patients

    Seq Age Sex Outcome Treatment
    1