BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 13938969 · Received March 29, 2022

    Report

    Report Number
    1037905-2022-00137
    Event Type
    Malfunction
    Date Received
    March 29, 2022
    Date of Event
    March 1, 2022
    Report Date
    May 4, 2022
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    QAU
    UDI-DI
    00827002565722
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMMON DEVICE NAME: HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE PRODUCT CODE: QAU SECTION G: 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. 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 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.

    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: 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. 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 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 ENDOSCOPIC PROCEDURE TO TREAT A BLEEDING ULCER IN THE GI TRACT, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED THAT THE PHYSICIAN FOLLOWED THE SET UP INSTRUCTIONS BUT THE DEVICE DID NOT FIRE [UNABLE TO SPRAY - SUBJECT OF REPORT]. THE PROCEDURE WAS COMPLETED USING CLIPS. AN UNINTENDED SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT REQUIRED CLIPS TO COMPLETE THE PROCEDURE 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 ESOPHAGOGASTRODUODENOSCOPY (EGD) TO TREAT A BLEEDING ULCER IN THE GI TRACT, THE PHYSICIAN USED A COOK HEMOSPRAY ENDOSCOPIC HEMOSTAT. IT WAS REPORTED THAT THE PHYSICIAN FOLLOWED THE SET UP INSTRUCTIONS BUT THE DEVICE DID NOT FIRE [UNABLE TO SPRAY - SUBJECT OF REPORT]. THE PROCEDURE WAS COMPLETED USING CLIPS. MEDWATCH REPORT (B)(4) FROM USER FACILITY RECEIVED 04/06/2022 WHICH STATED: "NARRATIVE FROM STAFF: HEMOSPRAY WOULD NOT WORK DURING AND EGD (ESOPHAGOGASTRODUODENOSCOPY) FOR A GI BLEED ONO AN ICU PATIENT. BUTTON PRESSED TO DISPERSE THE PRODUCT, BUT NOTHING HAPPENED. A SECOND ONE NEEDED TO BE OPENED. AN UNINTENDED SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. IT WAS ORIGINALLY REPORTED THAT CLIPS WERE USED, HOWEVER, THE MEDWATCH STATES THAT HEMOSPRAY WAS USED TO COMPLETE THE PROCEDURE. 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
    2904217 HEMOSPRAY ENDOSCOPIC HEMOSTAT QAU WILSON-COOK MEDICAL INC G56572 W4510179 00827002565722

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Unknown Required Intervention ENDOSCOPE - OLYMPUS, UNKNOWN MODEL