BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 15232064 · Received August 16, 2022

    Report

    Report Number
    1037905-2022-00473
    Event Type
    Malfunction
    Date Received
    August 16, 2022
    Date of Event
    July 20, 2022
    Report Date
    October 5, 2022
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    QAU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMMON DEVICE NAME: HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE. PRODUCT CODE: QAU. 510K: K200972. THE INVESTIGATION IS ON-GOING. A FOLLOW-UP EMDR WILL BE PROVIDED WITHIN 30 DAYS OF SUBMISSION OF THIS REPORT.

    Additional Manufacturer Narrative · 0

    CONTINUED: SECTION D: COMMON DEVICE NAME: HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE. PRODUCT CODE: QAU. SECTION G: 510K: K200972. THE INVESTIGATION REMAINS ON-GOING. A FOLLOW-UP EMDR WILL BE PROVIDED WITHIN 30 DAYS OF SUBMISSION OF THIS REPORT.

    Additional Manufacturer Narrative · 0

    CONTINUED: SECTION D: COMMON DEVICE NAME: HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE PRODUCT CODE: QAU. SECTION G: 510K: K200972. INVESTIGATION EVALUATION: THE PRODUCTS SAID TO BE INVOLVED WERE RETURNED IN AN OPEN TRAY WITHOUT A LID. NO LOT INFORMATION WAS PROVIDED. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. ALL COMPONENTS WERE NOT INCLUDED IN THE RETURN (NO CATHETERS WERE RETURNED), THEREFORE A COMPLETE EVALUATION WAS NOT POSSIBLE. THE DEVICE WAS RETURNED WITH THE ON/OFF SWITCH IN THE "ON" POSITION. THE RED ACTIVATION KNOB WAS ENGAGED IN THE HANDLE INDICATING ACTIVATION OF THE CARBON DIOXIDE (CO2) CARTRIDGE. POWDER WAS PRESENT ON THE EXTERIOR OF THE DEVICE. WHEN TESTED AS RETURNED, THE DEVICE DID NOT SPRAY. THE CO2 CARTRIDGE DID NOT DISCHARGE UPON DEACTIVATION OF THE DEVICE AND WAS FULLY PUNCTURED. A VISUAL EXAMINATION OF THE O-RING AND LANCE INSIDE THE HANDLE SHOWED BOTH COMPONENTS TO BE POSITIONED CORRECTLY INSIDE THE HANDLE AND THE LANCE TO BE BEVELED. THE INSPECTION OF THE CO2 CARTRIDGE AND REGULATOR (LANCE AND O-RING) CONFIRM THE DEVICE WAS OF THE CURRENT DESIGN. WHEN RETESTED WITH A NEW CO2 CARTRIDGE, THE DEVICE DID NOT SPRAY AS INTENDED. A HISSING SOUND WAS OBSERVED WHEN THE ACTIVATION BUTTON WAS PRESSED. THE DEVICE WAS DISASSEMBLED AND THE LOW PRESSURE VALVE TUBE LEADING TO THE POWDER CHAMBER WAS CONNECTED TO THE INCORRECT PEG DURING MANUFACTURING OF THE DEVICE. THIS INDICATES THAT CO2 WAS NOT TRAVELING INTO THE POWDER CHAMBER AND THROUGH THE DEVICE AS INTENDED. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSION: OUR LABORATORY INVESTIGATION CONFIRMED THAT THE DEVICE WAS UNABLE TO SPRAY DUE TO THE TUBING BETWEEN THE POWDER CHAMBER AND LOW PRESSURE VALVE BEING INCORRECTLY PLACED. THIS NONCONFORMANCE IS DUE TO OPERATOR ERROR. A NOTIFICATION OF OPERATOR RELATED COMPLAINT WAS SENT TO PRODUCTION MANAGEMENT ON 09/07/2022, AND A RECORD OF NOTIFICATION WAS SENT TO PRODUCTION AND QC MANAGEMENT ON 09/27/2022. ADDITIONALLY, RETRAINING ON THE PROCESS OF ASSEMBLING THE LOW PRESSURE VALVE WAS PERFORMED ON 08/22/2022 AS A RESULT OF THE LAB MEETING HELD WITH PRODUCTION SUPERVISION AND ENGINEERING ON 08/18/2022. PRIOR TO DISTRIBUTION, ALL HEMOSPRAY ENDOSCOPIC HEMOSTATS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Description of Event or Problem · 0

    DURING AN ENDOSCOPIC PROCEDURE TO TREAT A BLEEDING ULCER IN THE STOMACH, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED THAT THE POWDER DID NOT DEPLOY [SPRAY] OUT OF THE CONTAINER. THEY TRIED WITH BOTH CATHETERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1222839 HEMOSPRAY ENDOSCOPIC HEMOSTAT HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE QAU WILSON-COOK MEDICAL INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ENDOSCOPE - UNKNOWN MAKE OR MODEL.