BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE

    MDR report key: 19972244 · Received August 13, 2024

    Report

    Report Number
    3001845648-2024-00458
    Event Type
    Malfunction
    Date Received
    August 13, 2024
    Date of Event
    May 16, 2018
    Report Date
    December 12, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    KNS
    PMA / PMN Number
    K022595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION THIS FILE WAS OPEN TO CAPTURE THE OCCURRENCE OF ABNORMAL USE IN UNITED KINGDOM. THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE, "ENDOSCOPIC ULTRASOUND-GUIDED DRAINAGE OF PANCREATIC WALLED-OFF NECROSIS USING SELF-EXPANDING METAL STENTS WITHOUT FLUOROSCOPY". THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. ABNORMAL USE COMPLAINTS ARE CONSIDERED TO BE BEYOND ANY FURTHER REASONABLE MEANS OF INTERFACE-RELATED RISK CONTROL BY THE MANUFACTURER. IT IS UNKNOWN HOW THE DEVICE WILL FUNCTION OUTSIDE OF ITS INTENDED USE. TRENDING WILL MONITOR IF ANY FUTURE INVESTIGATION IS REQUIRED. IT SHOULD BE NOTED THAT THIS FILE IS RELATED TO ANOTHER COMPLAINTS FILE. FOR DETAILS OF THE OTHER INVESTIGATION PLEASE REFER TO PRS: (B)(4). MANUFACTURING RECORDS PRIOR TO DISTRIBUTION, ALL CST-10 DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. AS THE LOT NUMBER IS UNKNOWN A REVIEW OF MANUFACTURING RECORDS COULD NOT BE PERFORMED. INSTRUCTIONS FOR USE AND/LABEL AS PER THE INSTRUCTIONS FOR USE, IFU0005 WHICH ACCOMPANIES THIS DEVICE, INSTRUCTS THE USER "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. (IFU0005) IMAGE REVIEW AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS A DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED TO THE ABNORMAL USE OF THE DEVICE. FROM THE INFORMATION AVAILABLE, CST-10 DEVICE WAS USED IN A WOPN (WALLED-OFF PANCREATIC NECROSIS), THIS WAS CONFIRMED BY OUR MEDICAL ADVISOR AS ABNORMAL USE. AS PREVIOUSLY MENTIONED, THE IFU (IFU0005) STATES "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" AND IN THE NOTES SECTION ¿DO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN STATED IN THE INTENDED USE.¿ THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU WITH RESPECT TO THE INTENDED USE OF THE DEVICE. IT IS UNKNOWN HOW THE DEVICE WILL FUNCTION OUTSIDE OF ITS INTENDED USE. TRENDING WILL MONITOR IF ANY FUTURE INVESTIGATION IS REQUIRED. SUMMARY COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. ACCORDING TO THE INITIAL REPORTER, NO HEALTH CONSEQUENCES OR IMPACT REPORTED IN THE STUDY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS. INVESTIGATION FINDINGS CONCLUDE THAT A DEFINITIVE ROOT CAUSE OF ABNORMAL USE WAS DETERMINED FROM THE AVAILABLE INFORMATION.

    Description of Event or Problem · 0

    BRADEN, 2018 ¿ ENDOSCOPIC ULTRASOUND-GUIDED DRAINAGE OF PANCREATIC WALLED-OFF NECROSIS USING SELF-EXPANDING METAL STENTS WITHOUT FLUOROSCOPY FROM MAY 2014 WE STARTED A PROSPECTIVELY MAINTAINED DATABASE TO AUDIT CLINICAL OUTCOME OF EUS-GUIDED THERAPY OF PANCREATIC FLUID COLLECTIONS. EUS-GUIDED TRANSMURAL DRAINAGE OF WALLED-OFF NECROSIS BY FCSEMS INSERTION PERFORMED BETWEEN MAY 2014 AND AUGUST 2017 WERE ANALYSED. PARTICIPATING CENTERS WERE THE JOHN RADCLIFFE HOSPITAL IN OXFORD, UNITED KINGDOM AND THE CARITAS HOSPITAL IN BAD MERGENTHEIM, GERMANY. TRANSMURAL ACCESS INTO THE WOPN WAS ACHIEVED USING A CYSTOTOME (COOK ENDOSCOPY, WINSTON-SALEM, NC, UNITED STATES) OR DIRECTLY THE HOT AXIOSTM ELECTROCAUTERY SYSTEM (XLUMENA INC., MOUNTAIN VIEW, CA, UNITED STATES). A 0.035-INCH GUIDEWIRE WAS ADVANCED UNDER EUSGUIDANCE AND COILED AT LEAST TWICE INTO THE CAVITY TO STABILIZE THE POSITION. THE NEW TRACT WAS ENLARGED USING THE DIATHERMY OF THE CYSTOTOME OR THE AXIOSTM ELECTROCAUTERY SYSTEM BEFORE THE STENT DELIVERY SYSTEM (AXIOSTM OR NAGITM STENT, TAEWOONG MEDICAL, GYEONGGIDO, SOUTH KOREA) WAS INTRODUCED OVER THE GUIDEWIRE. THIS COMPLAINT WILL CAPTURE 27 CASES OF OFF LABEL USE OF USING CST-10 DEVICE IN WOPN THAT POTENTIALLY OCCURRED IN THE UK. PATIENT OUTCOME: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS 21 MALE AND 6 FEMALE PATIENTS AGES 45-63

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 12-DEC-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1620046 CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC KNS COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male