BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 18999576 · Received March 28, 2024

    Report

    Report Number
    1037905-2024-00184
    Event Type
    Injury
    Date Received
    March 28, 2024
    Date of Event
    February 11, 2024
    Report Date
    May 3, 2024
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    QAU
    UDI-DI
    00827002565722
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUED: SECTION G: 510K: K200972. INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN A CLEAR PLASTIC BAG, PROVIDED WITH THE RETURN WAS AN OPEN TRAY FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCT RETURNED. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. NOT ALL COMPONENTS WERE INCLUDED IN THE RETURN (ONLY 1 CATHETER WAS RETURNED). 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 AND WITHIN THE NOZZLE. THE DEVICE DID NOT SPRAY AS INTENDED AS RETURNED. THE CO2 CARTRIDGE WAS FULLY PUNCTURED. AN AUDIBLE DISCHARGE WAS NOT HEARD UPON DEACTIVATION OF THE CO2 CARTRIDGE. 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. THE FOAM WAS PRESENT AND IN THE CORRECT ORIENTATION (SLITS FACING THE RED ACTIVATION KNOB). WHEN TESTED WITH A NEW CO2 CARTRIDGE AND ACTIVATION KNOB, THE DEVICE RELEASED POWDER AND SPRAYED WEAKLY INITIALLY BUT FREQUENTLY NO POWDER WOULD EXIT THE DEVICE DESPITE AUDIBLE FLOW OF CO2 AND POWDER MIXING IN THE POWDER CHAMBER. LIGHTLY SHAKING THE DEVICE TO FILL ANY POSSIBLE VOIDS WITHIN THE POWDER CHAMBER DID NOT RECTIFY THIS. A SMALL AMOUNT OF POWDER WAS ABLE TO PASS THROUGH THE CATHETER INITIALLY BUT THE NO MORE EXITED DESPITE CO2 BEING RELEASED DURING BUTTON COMPRESSIONS. THE HANDLE WAS DISASSEMBLED, AND THE TUBES WERE DISCONNECTED FOR REMOVAL OF ANY POWDER. LOOSE POWDER WAS PRESENT IN THE FRONT TUBE CONNECTING THE ON/OFF VALVE TO THE POWDER CHAMBER, NO CLUMPS WERE NOTED. POWDER WAS NOT PRESENT IN THE BACK TUBE CONNECTING THE POWDER CHAMBER TO THE LOW PRESSURE VALVE. A VISUAL INSPECTION OF THE HOLE IN THE BOTTOM OF THE POWDER CHAMBER SHOWED IT TO BE CLEAR. THE LOW PRESSURE VALVE WAS DISASSEMBLED AND EVALUATED. ALL THE INTERNAL COMPONENTS WERE INTACT. HOWEVER, POWDER WAS OBSERVED AROUND THE BASE OF THE ACTIVATION BUTTON AND AROUND THE ORANGE O-RING INSIDE THE VALVE. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS REPORTED OCCURRENCE WAS NOT OBSERVED. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. THE ROOT CAUSE FOR REPORT OF UNABLE TO SPRAY WAS AN INTERNAL CLOG WITHIN THE DEVICE. THE CAUSE OF THE INTERNAL CLOG IS UNKNOWN. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS OF THE RETURNED PRODUCT. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. A CORRECTIVE ACTION (CAPA) WAS INITIATED TO FURTHER INVESTIGATE DEVICE FAILURE DUE TO BEING UNABLE TO SPRAY POWDER. THIS DEVICE IS WITHIN THE SCOPE OF THE CAPA. PRIOR TO DISTRIBUTION, ALL HEMOSPRAY ENDOSCOPIC HEMOSTATS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: A CORRECTIVE ACTION HAS BEEN INITIATED IN AN EFFORT TO REDUCE OCCURRENCES OF THIS NATURE. THIS PRODUCT IS INCLUDED IN THE SCOPE OF THIS CORRECTIVE ACTION. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    CONTINUED:. SECTION G: 510K: K200972 INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN A CLEAR PLASTIC BAG, PROVIDED WITH THE RETURN WAS AN OPEN TRAY FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCT RETURNED. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. NOT ALL COMPONENTS WERE INCLUDED IN THE RETURN (ONLY 1 CATHETER WAS RETURNED). 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 AND WITHIN THE NOZZLE. THE DEVICE DID NOT SPRAY AS INTENDED AS RETURNED. THE CO2 CARTRIDGE WAS FULLY PUNCTURED. AN AUDIBLE DISCHARGE WAS NOT HEARD UPON DEACTIVATION OF THE CO2 CARTRIDGE. 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. THE FOAM WAS PRESENT AND IN THE CORRECT ORIENTATION (SLITS FACING THE RED ACTIVATION KNOB). WHEN TESTED WITH A NEW CO2 CARTRIDGE AND ACTIVATION KNOB, THE DEVICE RELEASED POWDER AND SPRAYED WEAKLY INITIALLY BUT FREQUENTLY NO POWDER WOULD EXIT THE DEVICE DESPITE AUDIBLE FLOW OF CO2 AND POWDER MIXING IN THE POWDER CHAMBER. LIGHTLY SHAKING THE DEVICE TO FILL ANY POSSIBLE VOIDS WITHIN THE POWDER CHAMBER DID NOT RECTIFY THIS. A SMALL AMOUNT OF POWDER WAS ABLE TO PASS THROUGH THE CATHETER INITIALLY BUT THE NO MORE EXITED DESPITE CO2 BEING RELEASED DURING BUTTON COMPRESSIONS. THE HANDLE WAS DISASSEMBLED, AND THE TUBES WERE DISCONNECTED FOR REMOVAL OF ANY POWDER. LOOSE POWDER WAS PRESENT IN THE FRONT TUBE CONNECTING THE ON/OFF VALVE TO THE POWDER CHAMBER, NO CLUMPS WERE NOTED. POWDER WAS NOT PRESENT IN THE BACK TUBE CONNECTING THE POWDER CHAMBER TO THE LOW PRESSURE VALVE. A VISUAL INSPECTION OF THE HOLE IN THE BOTTOM OF THE POWDER CHAMBER SHOWED IT TO BE CLEAR. THE LOW PRESSURE VALVE WAS DISASSEMBLED AND EVALUATED. ALL THE INTERNAL COMPONENTS WERE INTACT. HOWEVER, POWDER WAS OBSERVED AROUND THE BASE OF THE ACTIVATION BUTTON AND AROUND THE ORANGE O-RING INSIDE THE VALVE. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS REPORTED OCCURRENCE WAS NOT OBSERVED. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. THE ROOT CAUSE FOR REPORT OF UNABLE TO SPRAY WAS AN INTERNAL CLOG WITHIN THE DEVICE. THE CAUSE OF THE INTERNAL CLOG IS UNKNOWN. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS OF THE RETURNED PRODUCT. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. A CORRECTIVE ACTION (CAPA) WAS INITIATED TO FURTHER INVESTIGATE DEVICE FAILURE DUE TO BEING UNABLE TO SPRAY POWDER. THIS DEVICE IS WITHIN THE SCOPE OF THE CAPA. PRIOR TO DISTRIBUTION, ALL HEMOSPRAY ENDOSCOPIC HEMOSTATS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: A CORRECTIVE ACTION HAS BEEN INITIATED IN AN EFFORT TO REDUCE OCCURRENCES OF THIS NATURE. THIS PRODUCT IS INCLUDED IN THE SCOPE OF THIS CORRECTIVE ACTION. 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 GASTROSCOPY, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. THEY WERE UNABLE TO GET THE POWDER OUT OF THE DEVICE [UNABLE TO SPRAY] DURING USE. THE DEVICE WAS TESTED REPEATEDLY WITH DIFFERENT PEOPLE, A SECOND CATHETER, SAME RESULT. PHYSICIAN DECIDED TO USE ANOTHER OF THE SAME DEVICE TO FINISH THE PROCEDURE. OUR ATTEMPTS TO CONFIRM WHAT OTHER MODALITIES OF HEMOSTASIS MAY HAVE BEEN USED HAVE BEEN UNSUCCESSFUL. 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.

    Description of Event or Problem · 0

    DURING AN GASTROSCOPY, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. THEY WERE UNABLE TO GET THE POWDER OUT OF THE DEVICE [UNABLE TO SPRAY] DURING USE. THE DEVICE WAS TESTED REPEATEDLY WITH DIFFERENT PEOPLE, A SECOND CATHETER, SAME RESULT. PHYSICIAN DECIDED TO USE ANOTHER UNKNOWN HEMOSTASIS METHOD. OUR ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING THE OTHER METHOD OF HEMOSTASIS HAVE BEEN UNSUCCESSFUL HOWEVER IT WAS COMMUNICATED THAT 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
    1928580 HEMOSPRAY ENDOSCOPIC HEMOSTAT HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE QAU WILSON-COOK MEDICAL INC W4772854 00827002565722

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention COLONOSCOPE OLYMPUS-UNKNOWN MODEL