BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTINCT ENDOSCOPIC HEMOCLIP

    MDR report key: 15403353 · Received September 12, 2022

    Report

    Report Number
    1037905-2022-00505
    Event Type
    Injury
    Date Received
    September 12, 2022
    Date of Event
    November 8, 2016
    Report Date
    September 12, 2022
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    PKL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K): K132809. 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. 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. HOWEVER, A DEVICE FAILURE WAS NOT REPORTED IN THE ARTICLE. ENDOSCOPIC MEASURES WERE NOT ABLE TO STOP THIS BLEED. THE INSTRUCTIONS FOR USE POTENTIAL COMPLICATIONS STATE: "THOSE ASSOCIATED WITH GASTROINTESTINAL ENDOSCOPY AND ENDOSCOPIC HEMOSTASIS INCLUDE, BUT ARE NOT LIMITED TO: PERFORATION, HEMORRHAGE, ASPIRATION, FEVER, INFECTION, ALLERGIC REACTION TO MEDICATION, HYPOTENSION, RESPIRATORY DEPRESSION OR ARREST, CARDIAC ARRHYTHMIA OR ARREST, HEMATEMESIS, TRANSIENT DYSPHAGIA, ASPIRATION PNEUMONIA, WOUND DEHISCENCE, MINIMAL ACUTE INFLAMMATORY TISSUE REACTION, TRANSITORY LOCAL IRRITATION, MIGRATION OF CLIP INTO THE BILE DUCT, AND ANATOMY DISRUPTION." PRIOR TO DISTRIBUTION, ALL INSTINCT ENDOSCOPIC HEMOCLIPS ARE SUBJECTED TO A VISUAL AND FUNCTIONAL 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. WANDER P, CASTANEDA D, D'SOUZA L, SINGH S, SEROUYA S, VELAZQUEZ AI, MAMUN R, VOAKLANDER R, BENIAS P, CARR-LOCKE DL. SINGLE CENTER EXPERIENCE OF A NEW ENDOSCOPIC CLIP IN MANAGING NONVARICEAL UPPER GASTROINTESTINAL BLEEDING. J CLIN GASTROENTEROL. 2018 APR;52(4):307-312. DOI: 10.1097/MCG.0000000000000785. PMID: 29517984.

    Description of Event or Problem · 0

    COOK BECAME AWARE OF THE CLINICAL LITERATURE ARTICLE INVOLVING COOK INSTINCT ENDOSCOPIC HEMOCLIP. SEE RELEVANT EXCERPTS: PATIENTS FROM MAY 2013 TO JAN 2016: "A RETROSPECTIVE DESCRIPTIVE CHART REVIEW WAS PERFORMED ON PATIENTS PRESENTING WITH RECENT OVERT GI BLEEDING TREATED WITH ENDOCLIP THERAPY AT (B)(6) MEDICAL CENTER. IN TOTAL, 178 CONSECUTIVE PATIENTS WITH UGIB WERE INCLUDED. INITIAL HEMOSTASIS WAS ACHIEVED IN 172 (96.6%) PATIENTS. INITIAL HEMOSTASIS WAS NOT ACHIEVED IN 6 (3.4%) PATIENTS [SUBJECT OF THIS REPORT]." NO INFORMATION WAS PROVIDED REGARDING INTERVENTION. THERE WERE NO ADVERSE EVENTS ASSOCIATED WITH CLIP USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1578680 INSTINCT ENDOSCOPIC HEMOCLIP PKL, LIGATOR, HEMORRHOIDAL PKL WILSON-COOK MEDICAL INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention