BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    MDR report key: 18677114 · Received February 9, 2024

    Report

    Report Number
    1037905-2024-00073
    Event Type
    Injury
    Date Received
    February 9, 2024
    Report Date
    February 9, 2024
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    PKL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    510(K): K212323 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. THE INSTRUCTIONS FOR USE (IFU) STATES, "POTENTIAL COMPLICATIONS 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 PLUS ENDOSCOPIC CLIPPING DEVICES 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 · 0

    COOK ENDOSCOPY WAS NOTIFIED OF THIS EVENT THROUGH A PMCF STUDY REPORT. THE PMCF PRESENTS A RETROSPECTIVE REVIEW OF DATA FROM AN OBSERVATIONAL POST-MARKET STUDY OF PATIENTS TREATED WITH INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICES EXTRACTED FROM EXISTING DATABASES IN THE US. PLEASE SEE BELOW FOR RELEVANT EXCERPTS OF THE REPORT. INDEX PROCEDURES FOR STUDY DEVICE PLACEMENT INCLUDED IN THE REPORT SPAN FROM 2021 THROUGH 2022. "DEVICE RELATED ADVERSE EVENTS ARE [LISTED BELOW]... THE MAJORITY OF THESE EVENTS WERE BLEEDING POST-PROCEDURE OR SYMPTOMS OF POST-PROCEDURE BLEEDING 90% (9/10). ONE SUPERFICIAL MUCOSAI INJURY WAS NOTED DUE TO THE PASSAGE OF THE CLIP IN THE OROPHARYNX, ALTHOUGH THE PATIENT ALSO HAD AN OVER THE SCOPE (OTS) CLIP USED DURING THE PROCEDURE AND THERE IS A HIGH LIKELIHOOD THE INJURY WAS CAUSED BY THE OTS CLIP. NO SIGNIFICANT TREATMENT WAS REQUIRED FOR MOST OF THESE EVENTS WITH A SINGLE PATIENT RECEIVING BIPOLAR CAUTERY TREATMENT FOR BLEEDING RESOLUTION..." PATIENT ID 9- USED FOR HEMOSTASIS- AE= POST-PROCEDURE BLEEDING. RESOLUTION= RESOLVED WITHOUT THERAPY, HOSPITAL ADMISSION IT WAS NOT STATED IN THE STUDY THAT AN UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. IT WAS STATED IN THE STUDY THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR THE POST-PROCEDURE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52158 INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE PKL, LIGATOR, HEMORRHOIDAL PKL WILSON-COOK MEDICAL INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization SCOPE, UNKNOWN MAKE AND MODEL