BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BICAP HEMOSTASIS PROBE 7FR

    MDR report key: 10295762 · Received July 20, 2020

    Report

    Report Number
    1320894-2020-00306
    Event Type
    Malfunction
    Date Received
    July 20, 2020
    Date of Event
    June 24, 2020
    Report Date
    November 17, 2020
    Manufacturer
    CONMED CORPORATION
    Product Code
    FEH
    PMA / PMN Number
    K803214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED BY THE REPORTER. DESPITE ATTEMPTS OVER THE PAST MONTH TO OBTAIN THE DEVICE FOR RETURN TO CONMED FOR EVALUATION, THE DEVICE HAS NOT BEEN LOCATED OR RETURNED TO CONMED BY THE FACILITY. ITS LOCATION IS UNKNOWN. NO PHOTOGRAPHIC EVIDENCE HAS BEEN PROVIDED. THEREFORE, THE REPORTED FAILURE CANNOT BE VERIFIED, AND ROOT CAUSE CAN NOT BE IDENTIFIED. SHOULD THE DEVICE BE RETURNED AN EVALUATION WILL BE PERFORMED AND UPON COMPLETION OF THE COMPLAINT INVESTIGATION A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD AND LOT HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WERE FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT AND FOUND NO ABNORMALITIES THAT WOULD CONTRIBUTE TO THIS ISSUE. A LOT HISTORY REVIEW WAS CONDUCTED AND FOUND THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE. 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 4,156 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 0.0005. THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE USER WITH INFORMATION REGARDING PROPER CARE AND USE OF THIS DEVICE. THE IFU ADVISES THE USER THAT CARE SHOULD BE TAKEN NOT TO DAMAGE THE PROBE WHILE ADVANCING IT THROUGH A SCOPE TIP BENT 15 DEGREES OR MORE. THE IFU ALSO ADVISES THE USER THAT THESE DEVICES SHOULD BE INSPECTED BEFORE USE AND DISCARDED IF COMPROMISED. VISUALLY EXAMINE THE DEVICES FOR OBVIOUS PHYSICAL DAMAGE AND DO NOT USE IF DAMAGE IS FOUND: CRACKED, BROKEN OR OTHERWISE DISTORTED PLASTIC PARTS, BROKEN OR SIGNIFICANTLY BENT SHAFT OR CONNECTOR CONTACTS, OPENED, DAMAGED OR COMPROMISED PACKAGE. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 0

    THE PRODUCT IN QUESTION WAS RETURNED TO CONMED FOR EVALUATION. THE REPORTED COMPLAINT OF THE PROBE TIP DETACHED EXPOSING WIRES AT THE DISTAL TIP IS NOW CONFIRMED. AN EXAMINATION OF THE RETURNED USED DEVICE, BP-7300A, QUANTITY OF 1, FOUND THERE ARE EXPOSED WIRES AT THE DISTAL END OF THE DEVICE WHERE THE PROBE IS ATTACHED. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED AND FOUND NO ABNORMALITIES THAT WOULD CONTRIBUTE TO THIS ISSUE. A LOT HISTORY REVIEW WAS CONDUCTED AND FOUND THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE. 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. THE IFU ADVISES THE USER THAT CARE SHOULD BE TAKEN NOT TO DAMAGE THE PROBE WHILE ADVANCING IT THROUGH A SCOPE TIP BENT 15 DEGREES OR MORE. THE IFU ALSO ADVISES THE USER THAT THESE DEVICES SHOULD BE INSPECTED BEFORE USE AND DISCARDED IF COMPROMISED. VISUALLY EXAMINE THE DEVICES FOR OBVIOUS PHYSICAL DAMAGE AND DO NOT USE IF DAMAGE IS FOUND: CRACKED, BROKEN OR OTHERWISE DISTORTED PLASTIC PARTS, BROKEN OR SIGNIFICANTLY BENT SHAFT OR CONNECTOR CONTACTS, OPENED, DAMAGED OR COMPROMISED PACKAGE. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION PROVIDED BY THE REPORTER INDICATES THE TECHNICIAN AND THE DOCTOR WERE USING THE BICAP HEMOSTASIS PROBE ON AN AVM. WHEN THEY REMOVED IT TO WIPE THE TIP OFF, THE WHOLE TIP FELL CAME OFF. SINCE THEY COULD SEE THE WIRES, THEY GRABBED ANOTHER BICAP AND PROCEEDED TO TREAT THE PATIENT. ALTHOUGH REQUESTED, THIS WAS THE ONLY ADDITIONAL INFORMATION MADE AVAILABLE.

    Additional Manufacturer Narrative · 1

    AT TIME OF FILING, ALTHOUGH EXPECTED, THE REPORTED DEVICE HAS NOT BEEN RETURNED TO CONMED FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    ON BEHALF OF THE CUSTOMER, THE CONMED REPRESENTATIVE REPORTED AN ISSUE INVOLVING THE BP-7300A, BICAP HEMOSTASIS PROBE 7FR, LOT # 201810081 THAT OCCURRED AT THE DIGESTIVE DISEASE CENTER IN (B)(6) ON (B)(6) 2020. IT WAS REPORTED THAT THE "PROBE TIP DETACHED WHICH EXPOSED WIRES AT DISTAL TIP" DURING USE IN SURGERY. IT IS ALSO NOTED THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER PROBE AND THERE WAS NO IMPACT OR INJURY TO THE PATIENT. ALTHOUGH MULTIPLE REQUESTS HAVE BEEN MADE, TO DATE, NO ADDITIONAL INFORMATION OR CLARIFICATION HAS BEEN MADE AVAILABLE. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE AS THE TIP DETACHED DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764091 BICAP HEMOSTASIS PROBE 7FR ELECTRODE, FLEXIBLE SUCTION COAGULATOR FEH CONMED CORPORATION 201810081

    Patients

    Seq Age Sex Outcome Treatment
    1