BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BICAP, HEMOSTASIS PROBE

    MDR report key: 11945811 · Received June 7, 2021

    Report

    Report Number
    1320894-2021-00285
    Event Type
    Injury
    Date Received
    June 7, 2021
    Date of Event
    May 22, 2021
    Report Date
    September 13, 2021
    Manufacturer
    CONMED CORPORATION
    Product Code
    FEH
    PMA / PMN Number
    K803214
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED ONE BP-7300A IN OPENED ORIGINAL PACKAGING. LOT NUMBER WAS VERIFIED. PERFORMED A VISUAL INSPECTION, THE DISTAL TIP OF THE DEVICE HAS A MELTED APPEARANCE. THE METAL TIP WAS NOT RETURNED WITH THE DEVICE. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE WITHIN THE PAST TWO YEARS. 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 0.0003. PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THAT THESE DEVICES SHOULD BE INSPECTED BEFORE USE AND DISCARDED IF COMPROMISED. VISUALLY EXAMINE THE DEVICES FOR OBVIOUS PHYSICAL 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

    ADDITIONAL INFORMATION: SINCE THE METAL TIP WAS NOT RETURNED FOR EVALUATION A CLEAR DETERMINATION OF THE CAUSE CANNOT BE DETERMINED. BUT BASED ON A REVIEW OF THE MANUFACTURING PROCEDURE THE TIP IS SOLDERED AND THEN THE ADHESIVE IS THEN ADDED TO THE TUBING ASSEMBLY (EITHER FAILURE BAD SOLDER JOINT OR IMPROPER ADHESION OF THE TIP TO THE TUBE) COULD HAVE CONTRIBUTED. THERE ARE IN PROCESS MITIGATION WHICH INCLUDE 100% CONTINUITY AND FUNCTIONAL TESTING FOR SOLDER JOINT ADEQUACY, AS WELL AS 100% LEAK TESTING AND SAMPLE-BASED PULL TESTING VIA PROCESS MONITORING FOR ADHESION OF THE TIP TO THE TUBE ASSEMBLY. ADDITIONALLY, POST MANUFACTURING POTENTIAL CAUSES INCLUDE INADEQUATE INSPECTION PER IFU AND IMPROPER USE (PRECAUTIONS). PER THE COMPLAINT DESCRIPTION, IT WAS INDICATED THAT A HIGHER POWER SETTING WAS REQUIRED DURING SURGERY WHICH COULD HAVE BEEN A CONTRIBUTING FACTOR TO THE FAILURE. A DETERMINATION COULD NOT BE MADE IF THE FAILURE MODE WAS DUE TO MANUFACTURING OR USER ERROR. RECEIVED ONE BP-7300A IN OPENED ORIGINAL PACKAGING. LOT NUMBER WAS VERIFIED. PERFORMED A VISUAL INSPECTION, THE DISTAL TIP OF THE DEVICE HAS A MELTED APPEARANCE. THE METAL TIP WAS NOT RETURNED WITH THE DEVICE. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE WITHIN THE PAST TWO YEARS. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THAT THESE DEVICES SHOULD BE INSPECTED BEFORE USE AND DISCARDED IF COMPROMISED. VISUALLY EXAMINE THE DEVICES FOR OBVIOUS PHYSICAL 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 · 1

    THE REPORTED DEVICE IS BEING 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

    THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE BP-7300A WAS BEING USED DURING A DUODENAL ULCER COAGULATION ON (B)(6) 2021 WHEN IT WAS REPORTED "THERE WAS A PROBLEM WITH LOW HEATING (WEAK COAGULATION), SO THE SURGEON INCREASED THE FREQUENCY. AFTER THAT, TIP WAS SUDDENLY DISCONNECTED FROM THE PROBE AND STAYED STICK ON PATIENT'S TISSUE." FURTHER REPORT STATES THAT THE TIP WAS NOT EXTRACTED, BUT YET STAPLED IN PLACE IN THE PATIENT DUE TO RISK OF INHALATION OF THE TIP. THE PROCEDURE WAS COMPLETED WITHOUT REPORT OF DELAY. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO COMPONENT LEFT IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844701 BICAP, HEMOSTASIS PROBE ELECTRODE, FLEXIBLE SUCTION COAGULATOR FEH CONMED CORPORATION 202003161

    Patients

    Seq Age Sex Outcome Treatment
    1 Other