BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 15440523 · Received September 16, 2022

    Report

    Report Number
    1037905-2022-00518
    Event Type
    Malfunction
    Date Received
    September 16, 2022
    Date of Event
    August 20, 2022
    Report Date
    October 11, 2022
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    QAU
    UDI-DI
    00827002565722
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 DEVICE WAS RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT. 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. INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN AN OPEN POUCH FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCT RETURNED. THE PICTURE PROVIDED SHOWS THE DEVICE TRAY LID WITH THE LOT INFORMATION. THE LOT NUMBER AND LABEL IN THE PHOTO MATCH THIS REPORT. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED COULD NOT CONFIRM THE REPORT. ALL COMPONENTS WERE INCLUDED IN THE RETURN. 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 RETURNED CATHETERS DID NOT CONTAIN POWDER INSIDE THE TUBING AND NO KINKS WERE PRESENT. THE DEVICE HAD A SMALL AMOUNT OF POWDER ON THE EXTERIOR. THE DEVICE WAS TESTED AS RETURNED AND SPRAYED AS INTENDED. THE RETURNED CATHETERS WERE ATTACHED TO THE NOZZLE FOR TESTING AND BOTH SPRAYED AS INTENDED. THE CO2 CARTRIDGE DISCHARGED WHEN DEACTIVATED 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. 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 LABORATORY EVALUATION OF THE RETURNED DEVICE COULD NOT CONFIRM THE REPORT BECAUSE THE DEVICE SPRAYED AS INTENDED WHEN TESTED AS RETURNED. 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. THE INSTRUCTIONS FOR USE STATES, "NOTE: DO NOT TEST DEVICE PRIOR TO INSERTION INTO ENDOSCOPE ACCESSORY CHANNEL AS THIS MAY INCREASE RISK OF CATHETER OCCLUSION." THE INFORMATION PROVIDED BY THE USER INDICATES THAT THE DEVICE WAS TESTED PRIOR TO USE. 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: 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 ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE TO TREAT A DUODENAL MASS BLEED, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. THE FOLLOWING WAS REPORTED, "PHYSICIAN ENTERS WITH ENDOSCOPE, REACHES DUODENUM, NOTICES DIFFUSE BLEEDING INJURIES AND REQUESTS HEMOSPRAY TO TRY AND STOP THE BLEEDING. TECH GRABS HEMOSPRAY KIT, OPENS PAPER LID, REMOVES PLASTIC TOP, GIVES PLASTIC CATHETER/TUBING TO PHYSICIAN, TECH GRABS HEMOSPRAY GUN, ACTIVATES CO2 [CARBON DIOXIDE] MECHANISM, OPENS TIP OF HEMOSPRAY GUN, PUSHES ¿FIRE¿ BUTTON ON HEMOSPRAY GUN BUT NO SPRAY COMES OUT. TECH TRIES AGAIN BUT AGAIN, NO SUCCESS. TECH DECIDES TO OPEN A SECOND HEMOSPRAY KIT, DIRECTLY ACTIVATES CO2 MECHANISM, TESTS THE GUN, SUCCESSFULLY TEST-SPRAY, FLUSHES PLASTIC CATHETER/ TUBING X3, CONNECTS HEMOSPRAY TO TUBING/CATHETER AND APPLIES SUCCESSFULLY." THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SECOND DEVICE. AN UNINTENDED 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
    126642 HEMOSPRAY ENDOSCOPIC HEMOSTAT Hemostatic device for endoscopic gastrointestinal use QAU WILSON-COOK MEDICAL INC G56572 W4580641 00827002565722

    Patients

    Seq Age Sex Outcome Treatment
    1 Female ENDOSCOPE - OLYMPUS GIF-190.