BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 13827948 · Received March 19, 2022

    Report

    Report Number
    1037905-2022-00120
    Event Type
    Injury
    Date Received
    March 19, 2022
    Date of Event
    February 18, 2022
    Report Date
    April 25, 2022
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    QAU
    UDI-DI
    00827002246638
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    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. INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. A PHOTO OF THE LID STOCK WITH THE LABEL WAS PROVIDED, THE LABEL MATCHES THE PRODUCT AND LOT # REPORTED. THE REPORT COULD NOT BE CONFIRMED. 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: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. PRIOR TO DISTRIBUTION, ALL HEMOSPRAY KITS 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 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.

    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 PRODUCT SAID TO BE INVOLVED WAS RETURNED IN A YELLOW BIOBAG WITH THE LID STOCK FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCT RETURNED. A PHOTO OF THE LID STOCK WITH THE LABEL WAS PROVIDED, THE LABEL MATCHES THE PRODUCT AND LOT# REPORTED. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED COULD NOT CONFIRM 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 "OFF" POSITION. THE RED ACTIVATION KNOB WAS ENGAGED IN THE HANDLE INDICATING ACTIVATION OF THE CARBON DIOXIDE (CO2) CARTRIDGE. THE EXTERIOR OF THE DEVICE PRESENTED WITH POWDER ON IT. THE DEVICE WAS TESTED AS RETURNED AND DID NOT SPRAY. THE CO2 CARTRIDGE WAS FULLY PUNCTURED. THE LANCE POSITION WAS MEASURED AND FOUND TO BE POSITIONED CORRECTLY. 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. WHEN TESTED WITH A NEW CO2 CARTRIDGE AND ACTIVATION KNOB, THE DEVICE SPRAYED AS INTENDED. 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: THE ROOT CAUSE FOR THE REPORT OF UNABLE TO SPRAY 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. CATHETER OCCLUSION CAN BE A CAUSE OF THIS DEVICE NOT BEING ABLE TO SPRAY POWDER. HOWEVER, WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE NO CATHETERS WERE RETURNED FOR EVALUATION. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. PRIOR TO DISTRIBUTION, ALL HEMOSPRAY KITS 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: 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 DUODENAL ULCER, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED "THE CO2 [CARBON DIOXIDE] FINISHED AFTER 5-6 TIMES OF DEPLOY" [SPRAY]. INJECTION THERAPY WAS THEN USED TO ACHIEVE HEMOSTASIS. AN UNINTENDED SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT REQUIRED AN INJECTION THERAPY TO ACHIEVE HEMOSTASIS 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
    532198 HEMOSPRAY ENDOSCOPIC HEMOSTAT QAU WILSON-COOK MEDICAL INC W4467531 00827002246638

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Other ENDOSCOPE-OLYMPUS, GIF H190.