BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE

    MDR report key: 8302865 · Received February 4, 2019

    Report

    Report Number
    3001845648-2019-00039
    Event Type
    Malfunction
    Date Received
    February 4, 2019
    Report Date
    January 7, 2019
    Manufacturer
    COOK IRELAND LTD
    Product Code
    KNS
    PMA / PMN Number
    K022595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # = K022595. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G.1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. DEVICE EVALUATION: DEVICE WAS NOT RETURNED THEREFORE A DOCUMENT BASED REVIEW WILL BE PERFORMED. PRIOR TO DISTRIBUTION, ALL CST-10 DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. AS THE LOT NUMBER IS UNKNOWN THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS PART OF THE INVESTIGATION. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO INSPECT THE DEVICE PRIOR TO USE : "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE". THE INTENDED USE SECTION DETAILS "THE DEVICE IS DESIGNED TO ELECTROSURGICALLY PUNCTURE A HOLE IN THE TRANSGASTRIC OR TRANSDUODENAL WALL AND INTO A PANCREATIC PSEUDOCYST, WHEN IT IS VISIBLY BULGING INTO THE GASTROINTESTINAL TRACT". THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE IN RELATION TO INTENDED USE. THE FAILURE OF ADVANCEMENT DIFFICULT WAS CONCLUDED FROM THE AVAILABLE INFORMATION. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE CAUSE COULD BE ATTRIBUTED TO OFF LABEL USE AS THE CST-10 DEVICE IS INTENDED TO PUNCTURE PANCREATIC PSEUDOCYSTS ONLY BUT THE COMPLAINT DESCRIPTION STATES TRYING TO ADVANCE INTO THE INTRAHEPATIC DUCTS. COMPLAINT IS CONFIRMED BASED ON THE CUSTOMER'S TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    THEY LOST WIRE GUIDE ACCESS. THEY WERE TRYING TO ADVANCE THE CYSTOTOME INTO THE INTRAHEPATIC DUCTS AND LOST ACCESS WITH THE WIRE GUIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96039 CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC KNS COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1