BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRI-TOME PC PROTECTOR

    MDR report key: 12150741 · Received July 12, 2021

    Report

    Report Number
    1037905-2021-00305
    Event Type
    Injury
    Date Received
    July 12, 2021
    Date of Event
    June 14, 2021
    Report Date
    August 6, 2021
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNS
    UDI-DI
    10827002491974
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION G, PMA/510(K) # K172665. INVESTIGATION EVALUATION: OUR EVALUATION OF THE PRODUCT SAID TO BE INVOLVED COULD NOT CONFIRM THE REPORT AS IT WAS DESCRIBED. THE CUTTING WIRE DIAMETER WAS MEASURED IN TWO DIFFERENT LOCATIONS, AT THE DISTAL AND PROXIMAL ENDS OF THE CUTTING WIRE. ALL THE MEASUREMENTS TAKEN ARE WITHIN SPECIFICATION. THE CUTTING WIRE WAS ALSO BENT, AND THE WIRE EXHIBITS EVIDENCE OF A CAUTERY APPLICATION (BLACKENING OF THE CUTTING WIRE WAS NOTED). FURTHER TESTING WAS CONDUCTED UTILIZING A VALLEY LAB ELECTROSURGICAL UNIT. THE SPHINCTEROTOME WAS CONNECTED TO THE UNIT WITH AN ACTIVE CORD FROM OUR SHELF STOCK. A SIMULATED TISSUE SAMPLE WAS ALSO UTILIZED DURING THE TEST. DURING TESTING, THE CUTTING WIRE OF THE SPHINCTEROTOME WAS OBSERVED CUTTING THE TISSUE SUCCESSFULLY. WE WERE UNABLE TO RECREATE DIFFICULTY EXPERIENCED BY THE USER. 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 DEVICE FUNCTIONED AS INTENDED. ALL MEASUREMENTS TAKEN REGARDING THE CUTTING WIRE LENGTHS AND DIMENSIONS WERE WITHIN SPECIFICATION. FUNCTIONAL TESTING OF THE DEVICE WAS ALSO SUCCESSFUL. PRIOR TO DISTRIBUTION, ALL TRI-TOME PC PROTECTORS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. 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 AND THIS REPRESENTS AN UNUSUAL OCCURRENCE. 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.

    Description of Event or Problem · 0

    DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE, THE PHYSICIAN USED A COOK TRI-TOME PC PROTECTOR. WHEN THE PHYSICIAN CUT THE VATER'S PAPILLA, BLEEDING OCCURRED. HE CHECKED THE CUTTING WIRE AND FOUND IT LOOKED THINNER THAN BEFORE. [THE PHYSICIAN STATED THAT] IT COULD CAUSE INCREASING OF HEAT CONDUCTIVITY. THE BOUNDARIES OF HEAT INSULATION COATING ARE UNCLEAR AS WELL. THE USER MANAGED TO STOP BLEEDING AND PLACED THE TUBE STENT TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PROCEDURE WAS FINISHED WITH ANOTHER MANUFACTURERS' EST KNIFE ON A DIFFERENT DAY DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT EXPERIENCED BLEEDING AND PER ADDITIONAL INFORMATION RECEIVED ON 7/14/2021, THE PHYSICIAN STOPPED THE BLEEDING WITH APC (ARGON PLASMA COAGULATION) AND AN UNSPECIFIED DRUG.

    Additional Manufacturer Narrative · 1

    PMA/510(K) # K172665. THE INVESTIGATION IS ON-GOING. A FOLLOW-UP EMDR WILL BE PROVIDED.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE, THE PHYSICIAN USED A COOK TRI-TOME PC PROTECTOR. WHEN THE PHYSICIAN CUT THE VATER'S PAPILLA, BLEEDING OCCURRED. HE CHECKED THE CUTTING WIRE AND FOUND IT LOOKED THINNER THAN BEFORE. [THE PHYSICIAN STATED THAT] IT COULD CAUSE INCREASING OF HEAT CONDUCTIVITY. THE BOUNDARIES OF HEAT INSULATION COATING ARE UNCLEAR AS WELL. THE USER MANAGED TO STOP BLEEDING AND PLACED THE TUBE STENT TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PROCEDURE WAS FINISHED WITH ANOTHER MANUFACTURERS' EST KNIFE ON A DIFFERENT DAY DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT EXPERIENCED BLEEDING AND THE PHYSICIAN STOPPED THE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1048436 TRI-TOME PC PROTECTOR KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS COOK ENDOSCOPY W4331520 10827002491974

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention OLYMPUS ENDOSCOPE / MODEL UNKNOWN| VIO ELECTROSURGICAL GENERATOR| OLYMPUS ENDOSCOPE / MODEL UNKNOWN| VIO ELECTROSURGICAL GENERATOR