BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRI-TOME PC PROTECTOR

    MDR report key: 12168984 · Received July 14, 2021

    Report

    Report Number
    1037905-2021-00310
    Event Type
    Malfunction
    Date Received
    July 14, 2021
    Date of Event
    June 21, 2021
    Report Date
    July 14, 2021
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER; OCCUPATION: UNKNOWN. PMA/510(K) # K172665. 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. RESPONSES TO ADDITIONAL QUESTIONS INDICATED THAT THE DISTAL END OF THE DEVICE WAS FORMED MANUALLY. THE INSTRUCTIONS FOR USE ADVISE THE USER: ¿DO NOT APPLY MANUAL PRESSURE TO THE TIP OR THE CUTTING WIRE OF THE SPHINCTEROTOME IN AN ATTEMPT TO INFLUENCE ORIENTATION, AS THIS MAY RESULT IN DAMAGE TO THE DEVICE." THIS IS THE MOST LIKELY CAUSE FOR THE REPORTED OBSERVATION. PRIOR TO DISTRIBUTION, ALL TRI-TOME PC PROTECTORS ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST 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. ADDITIONAL COMMENTS REGARDING THIS REPORT: BASED ON THE INFORMATION PROVIDED THAT THE DISTAL END OF THE DEVICE WAS FORMED MANUALLY, A COOK REPRESENTATIVE HAS BEEN DIRECTED TO CONTACT THE MEDICAL FACILITY INVOLVED IN AN EFFORT TO PROMOTE FURTHER EDUCATION AND UNDERSTANDING RELATED TO APPROPRIATE USAGE OF THIS PRODUCT.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK FUSION OMNI-TOME. THE PHYSICIAN TRIED TO [DO AN] ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE AFTER SUCCESSFUL CANNULATION, THE CUTTING WIRE BROKE. PER ADDITIONAL INFORMATION RECEIVED ON 06/28/2021 THE CUTTING WIRE ANCHOR DISCONNECTED AT THE PATIENT END OF THE DEVICE. 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
    1065819 TRI-TOME PC PROTECTOR KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS COOK ENDOSCOPY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1