BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 21028027 · Received December 27, 2024

    Report

    Report Number
    1037905-2024-00848
    Event Type
    Injury
    Date Received
    December 27, 2024
    Date of Event
    December 4, 2024
    Report Date
    February 13, 2025
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    QAU
    UDI-DI
    00827002210493
    PMA / PMN Number
    K200972
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUED: SECTION G: 510K: K200972. DEVICE RETURNED FOR EVALUATION ON 20JAN2025. 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 G: 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

    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 COULD NOT CONFIRM THE REPORT. NOT ALL COMPONENTS WERE INCLUDED IN THE RETURN (ONLY 1 CATHETER WAS RETURNED). THE RETURNED CATHETER DID NOT SHOW SIGNS OF USE (NO DISCOLORATION, POWDER WITHIN OR KINKS OBSERVED). THE DEVICE WAS RETURNED WITH THE ON/OFF SWITCH IN THE "OFF" POSITION. THE RED ACTIVATION KNOB WAS ENGAGED IN THE HANDLE INDICATING ACTIVATION OF THE CARBON DIOXIDE (CO2) CARTRIDGE. NO LOOSE POWDER WAS NOTED ON THE EXTERIOR OF THE DEVICE OR IN THE TRAY. A SMALL AMOUNT OF RESIDUAL POWDER WAS NOTED WITHIN THE DEVICE NOZZLE. WHEN TESTED AS RETURNED THE DEVICE DID NOT SPRAY. THE CO2 CARTRIDGE DID NOT AUDIBLY DISCHARGE UPON DEACTIVATION AND THE CARTRIDGE 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. 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 SPRAYED AS INTENDED BOTH WITH AND WITHOUT THE PROVIDED CATHETER CONNECTED. NO AUDIBLE ESCAPE OF CO2 WAS OBSERVED WHILE THE DEVICE WAS ACTIVATED AND IDLE. ADDITIONALLY, WHEN TESTED WITH A NEW CO2 CARTRIDGE AND THE RETURNED ACTIVATION KNOB THE DEVICE SPRAYED AS INTENDED WITH NO AUDIBLE ESCAPE OF CO2 OBSERVED WHILE THE DEVICE WAS ACTIVATED AND IDLE. 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 COULD NOT CONFIRM THE REPORT. A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED BECAUSE THE ACTUAL PRODUCT HANDLING CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. WHILE THE DEVICE, AS RETURNED, HAD THE RED ACTIVATION KNOB TIGHTENED WITHOUT ANY GAP, INDICATING SUFFICIENT TIGHTENING OF THE HANDLE, THE LEAKAGE DESCRIBED BY THE USER AT THE RED ACTIVATION KNOB CAN OCCUR IF THE ACTIVATION KNOB IS NOT FULLY TIGHTENED OR IS LEFT IN A PARTIALLY TIGHTENED STATE PRIOR TO FULLY TIGHTENING THE KNOB. THIS WOULD ALLOW THE CO2 TO ESCAPE. TO ASSIST THE USER THE IFU STATES: "ACTIVATE CO2 CARTRIDGE BY TURNING RED ACTIVATION KNOB UNTIL IT STOPS." 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 (CAPA) WAS INITIATED TO FURTHER INVESTIGATE DEVICE FAILURE DUE TO BEING UNABLE TO SPRAY POWDER. THE PRODUCT SAID TO BE INVOLVED IS INCLUDED IN THE SCOPE OF THE CORRECTIVE ACTION. A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 0

    IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED THAT THEY WANTED TO USE THE PRODUCT BUT WHEN THEY DID THE FIRST STEP "ACTIVATING THE SPRAY" IT JUST MADE A LOUD HISS SOUND AND THEN NO PRODUCT WAS COMING OUT. AFTER THE SYSTEM FAILED, THEY HAD TO USE ADRENALIN INJECTIONS, WHICH DID NOT WORK TO WELL. THIS OCCURRED PRIOR TO PATIENT CONTACT. AT THE TIME OF THIS REPORT, OUR ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME HAVE BEEN UNSUCCESSFUL. WHILE THE COMPLAINANT DID NOT SPECIFY IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS OR REQUIRED ADDITIONAL MEDICAL PROCEDURES DUE TO THIS EVENT, THE INFORMATION ABLE TO BE COLLECTED DOES NOT REASONABLY SUGGEST THE PATIENT WAS ADVERSELY IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2512324 HEMOSPRAY ENDOSCOPIC HEMOSTAT HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE QAU WILSON-COOK MEDICAL INC G21049 W4760432 00827002210493

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention UNKNOWN ENDOSCOPE.