BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE

    MDR report key: 8423873 · Received March 15, 2019

    Report

    Report Number
    3001845648-2019-00106
    Event Type
    Malfunction
    Date Received
    March 15, 2019
    Date of Event
    January 23, 2019
    Report Date
    March 15, 2019
    Manufacturer
    COOK IRELAND LTD
    Product Code
    KNS
    UDI-DI
    00827002305502
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    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 (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). DEVICE EVALUATION: 1 X CST-10 OF LOT NUMBER C1545960 WAS RETURNED TO CIRL FOR EVALUATION OPENED IN ITS ORIGINAL PACKAGING. LAB EVALUATION: THE DEVICE INVOLVED IN THE COMPLAINT WAS EVALUATED IN THE LABORATORY ON (B)(6) 2019. THE INNER CATHETER WAS OBSERVED TO BE CRUMPLED AND IT WAS NOTED THAT 2 STYLETS WERE RETURNED WITH THE DEVICE. THE FOLLOWING INFORMATION WAS REQUESTED POST LAB EVALUATION: ¿WHAT SIZE WIRE GUIDE WAS USED? WAS THE CYSTOME ADVANCED OVER A PRE-POSITIONED WIRE GUIDE?¿ TO WHICH THE REPORTER RESPONDED: ¿THE SIZE OF THE WIRE IS 0,35¿ AND CYSTOTOME ADVANCED ON THE WIRE GUIDE¿ IMAGE REVIEW: N/A. DOCUMENT REVIEW INCLUDING IFU REVIEW: PRIOR TO DISTRIBUTION CST-10 DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. A REVIEW OF THE MANUFACTURING RECORDS FOR CST-10 OF LOT NUMBER C1545960 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE REVIEW OF RELEVANT MANUFACTURING RECORDS, CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED WITH THE CURRENT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1545960. AS PER THE INSTRUCTIONS FOR USE, IFU0005-9, STEP 10: ¿NOTE: BEFORE EACH INTRODUCTION OF A WIRE GUIDE INTO A DEVICE, WET WIRE GUIDE IN A STERILE WATER OR SALINE BATH. A CONTRAST FILLED CATHETER MAY MAKE WIRE GUIDE DIFFICULT TO ADVANCE. FLUSH CONTRAST FROM CATHETER WITH WATER OR SALINE BEFORE EACH INTRODUCTION OF WIRE GUIDE. ADVANCE WIRE GUIDE INTO PANCREATIC PSEUDOCYST TO FACILITATE THE INTRODUCTION OF A STENT OR DRAINAGE SET¿. ROOT CAUSE REVIEW: A DEFINITE ROOT CAUSE CANNOT BE DETERMINED, AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE CONTRIBUTING FACTOR TO THE ISSUES ENCOUNTERED MAY BE DUE TO USER ERROR. IT WAS CONFIRMED THAT THE CYSTOME WAS ONTO A PREPOSITIONED WIREGUIDE. ADVANCING THE DEVICE INTO THE ENDOSCOPE OVER A PREPOSITIONED WIRE GUIDE IS NOT FOLLOWING THE PROCEDURAL STEPS OUTLINED IN THE IFU. AS PER INFORMATION PROVIDED: ¿I EXAMINED IT AND IT TURNS OUT THAT THE CATHETER IS DEFORMED AND A LITTLE MELTED... IT SEEMS TO ME THAT THIS IS A MISUSE OF THE PRODUCT BY OPERATORS.¿ SUMMARY: COMPLAINT IS CONFIRMED AS BASED ON CUSTOMER TESTIMONY AS THE CLINICAL SETTINGS THAT COULD IMPACT ON THE FUNCTIONALITY OF THE DEVICE CANNOT BE REPLICATED IN THE LABORATORY. AS PER INFORMATION PROVIDED, THERE WERE NO ADVERSE EFFECTS ON THE PATIENT AS A RESULT OF THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    CYSTOTOME CREATES A FISTULA BETWEEN THE STOMACH AND THE PANCREATIC DUCT. THIS DEVICE COULD NOT BE SET UP ON THE GUIDE BECAUSE OF A SIGNIFICANT FRICTION. FURTHER ABNORMAL DIFFICULTY FOR REMOVAL OF THE INTERNAL STYLET AND REMOVAL OF THE GUIDE IN PLACE. RENEWAL WITH A SECOND DM IDENTICAL GUIDE) UNDER THE SAME CONDITIONS WENT SMOOTHLY. PATIENT INJURY TO BE CONFIRMED.

    Description of Event or Problem · 0

    CYSTOTOME CREATES A FISTULA BETWEEN THE STOMACH AND THE PANCREATIC DUCT. THIS DEVICE COULD NOT BE SET UP ON THE GUIDE BECAUSE OF A SIGNIFICANT FRICTION. FURTHER ABNORMAL DIFFICULTY FOR REMOVAL OF THE INTERNAL STYLET AND REMOVAL OF THE GUIDE IN PLACE.RENEWAL WITH A SECOND DM IDENTICAL GUIDE) UNDER THE SAME CONDITIONS WENT SMOOTHLY. PATIENT INJURY TO BE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219167 CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC KNS COOK IRELAND LTD G30550 C1545960 00827002305502

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening