BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPRAY ENDOSCOPIC HEMOSTAT

    MDR report key: 12086237 · Received June 29, 2021

    Report

    Report Number
    1037905-2021-00285
    Event Type
    Malfunction
    Date Received
    June 29, 2021
    Date of Event
    June 7, 2021
    Report Date
    June 29, 2021
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    QAU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REGARDING SUSPECT MEDICAL DEVICE SECTION. COMMON DEVICE NAME: HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE PRODUCT CODE: QAU. INFORMATION REGARDING PMA/510(K): K200972. INVESTIGATION EVALUATION: A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. 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. THE INSTRUCTIONS FOR USE INCLUDE THE FOLLOWING POTENTIAL COMPLICATION: "WHEN SPRAYING IN RETROFLEXED POSITION, HEMOSPRAY POWDER MAY ADHERE TO THE OUTSIDE OF THE ENDOSCOPE. THIS MAY RESULT IN DIFFICULTY REPOSITIONING/REMOVING THE ENDOSCOPE, PARTICULARLY IF PASSING THROUGH A STRICTURED AREA." PRIOR TO DISTRIBUTION, ALL HEMOSPRAY ENDOSCOPIC HEMOSTATS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. 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 · 1

    DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A HEMOSPRAY ENDOSCOPIC HEMOSTAT. THE CUSTOMER USED HEMOSPRAY ON A PATIENT WITH BLEEDING LA GRADE D ESOPHAGITIS. DEPLOYMENT OF THE SPRAY (4 SPRAYS) IN THE DISTAL ESOPHAGUS WAS UNEVENTFUL, BUT THE CUSTOMER SUBSEQUENTLY HAD CONSIDERABLE DIFFICULTY REMOVING THE ENDOSCOPE FROM THE PATIENT. IT APPEARS THAT THE HEMOSPRAY COATED THE DISTAL 15 CM OF THE ENDOSCOPE AND MUST HAVE BEGUN TO STICK TO DISTAL ESOPHAGUS. MODERATE TORSION AND BACK AND FORTH MOVEMENT OF THE INSERTION WAS NEEDED TO FREE IT UP AND ALLOW WITHDRAWAL OF THE INSTRUMENT. THE CUSTOMER WAS SIGNIFICANTLY CONCERNED ABOUT MUCOSAL INJURY RESULTING FROM THE BINDING OF THE INSTRUMENT TO THE MUCOSA. OUR ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME WERE 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. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY AS THE SCOPE WAS ABLE TO BE WITHDRAWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986622 HEMOSPRAY ENDOSCOPIC HEMOSTAT QAU COOK ENDOSCOPY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1