BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRI-TOME PC PROTECTOR

    MDR report key: 12318166 · Received August 13, 2021

    Report

    Report Number
    1037905-2021-00382
    Event Type
    Malfunction
    Date Received
    August 13, 2021
    Date of Event
    July 5, 2021
    Report Date
    August 13, 2021
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNS
    UDI-DI
    10827002491974
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER; OCCUPATION: UNKNOWN. PMA/510(K) # K172665. INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED DETERMINED THE DISTAL TIP OF THE DEVICE APPEARS TO BE DISTORTED/DAMAGED. IT IS NOT KNOWN AT WHAT POINT THE DISTAL TIP BECAME DISTORTED/DAMAGED. NO SECTION OF THE SPHINCTEROTOME DEVICE WAS MISSING, AND THE DEVICE RESPONDED PROPERLY TO HANDLE MANIPULATION. THE CUTTING WIRE SECURING COMPONENT (ANCHOR) ALSO REMAINS FULLY ATTACHED TO THE CATHETER. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS REPORTED OCCURRENCE WAS NOT OBSERVED. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSION: A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PATIENT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LABORATORY ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. DAMAGE TO THE CATHETER TIP CAN OCCUR IF THE PRECURVED STYLET IS FORCEFULLY REMOVED. THE INSTRUCTIONS FOR USE INSTRUCT THE USER: ¿UPON REMOVING DEVICE FROM PACKAGE, UNCOIL AND STRAIGHTEN SPHINCTEROTOME. CAREFULLY REMOVE PRECURVED STYLET FROM CANNULATING TIP." IF THE ELEVATOR OF THE ENDOSCOPE REMAINS IN THE CLOSED/UP POSITION WHEN RETRACTION OF THE SPHINCTEROTOME IS ATTEMPTED AND IF ADDITIONAL PRESSURE IS APPLIED, THIS COULD CONTRIBUTE TO DAMAGE AT THE CATHETER TIP. THE INSTRUCTIONS FOR USE CAUTION THE USER: "ELEVATOR SHOULD REMAIN OPEN/DOWN WHEN ADVANCING OR RETRACTING SPHINCTEROTOME." THIS ACTIVITY WILL AID IN DEVICE PRESERVATION. THE INSTRUCTIONS FOR USE ALSO ADVISE THE USER TO: ¿VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE." PRIOR TO DISTRIBUTION, ALL TRI-TOME PC PROTECTORS ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST TO ENSURE DEVICE INTEGRITY. THE FUNCTIONAL TEST INCLUDES BOWING THE SPHINCTEROTOME TO ENSURE THE DISTAL END RESPONDS TO HANDLE MANIPULATION. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED REMOTE. 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 · 1

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK TRI-TOME PC PROTECTOR. THE PHYSICIAN ADVANCED THE DEVICE THROUGH THE WIRE GUIDE TO THE DUODENAL PAPILLA AND FOUND OUT THAT THERE WAS SOMETHING WRONG WITH THE TIP OF THE CUTTING WIRE UNDER ENDOSCOPY VIEW. THE PHYSICIAN THEN RETRACTED THE DEVICE ALONG WITH THE WIRE GUIDE FROM THE PATIENT, AND DETECTED THAT THE TIP OF CUTTING WIRE WAS BROKEN. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. OUR EVALUATION OF THE RETURNED DEVICE DETERMINED THAT THE CUTTING WIRE IS NOT BROKEN BUT THE TIP OF THE DEVICE IS DAMAGED AT THE WIRE GUIDE LUMEN [SUBJECT OF REPORT]. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1217377 TRI-TOME PC PROTECTOR KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS COOK ENDOSCOPY W4402312 10827002491974

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR COOK WIRE GUIDE ACRO-35-450.| OLYMPUS ENDOSCOPE TJF-260V.