BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTINCT ENDOSCOPIC HEMOCLIP

    MDR report key: 12333248 · Received August 17, 2021

    Report

    Report Number
    1037905-2021-00388
    Event Type
    Injury
    Date Received
    August 17, 2021
    Report Date
    September 14, 2021
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    PKL
    UDI-DI
    00827002183438
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K192697. 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 PRODUCT POUCH WAS RETURNED EMPTY, THE LOT NUMBER ON THE POUCH MATCHES THE LOT NUMBER IN THE REPORT. 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 INSTINCT ENDOSCOPIC HEMOCLIPS ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING 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 REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED REMOTE. 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 · 1

    PMA/510(K) # K192697. A FOLLOW-UP EMDR WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    DURING AN UPPER ENDOSCOPY PROCEDURE, THE PHYSICIAN USED A COOK INSTINCT ENDOSCOPIC HEMOCLIP. THE CLIP MADE CONTACT WITH THE TISSUE AND DEPLOYED, BUT THE CLIP DID NOT HOLD AND FELL OFF THE TISSUE. THIS CAUSED ADDITIONAL BLEEDING. THE PROCEDURE WAS COMPLETED WITH AN ADDITIONAL CLIP. THE CLIP REMAINED INSIDE THE PATIENT¿S BODY TO PASS NATURALLY. THE PATIENT REQUIRED HEMOSTASIS WITH AN ADDITIONAL CLIP. ACCORDING TO THE INITIAL REPORTER, THE PATIENT EXPERIENCED ADDITIONAL BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1228819 INSTINCT ENDOSCOPIC HEMOCLIP PKL, LIGATOR, HEMORRHOIDAL PKL COOK ENDOSCOPY G18343 W4405071 00827002183438

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention OLYMPUS ENDOSCOPE, GIF-H190