BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME

    MDR report key: 10030666 · Received May 6, 2020

    Report

    Report Number
    1037905-2020-00197
    Event Type
    Injury
    Date Received
    May 6, 2020
    Date of Event
    November 18, 2016
    Report Date
    April 7, 2020
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNS
    PMA / PMN Number
    K901443
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUE FROM CONCOMITANT PRODUCTS: ZEBRA WIRE GUIDE, MTW-0.027. COOK MEMORY HARD WIRE BASKET, MWB-3X6. COOK TRI-EX TRIPLE LUMEN EXTRACTION BALLOON, TX-15-A. YIN, P., WANG, M., QIN, R. ET AL. INTRAOPERATIVE ENDOSCOPIC NASOBILIARY DRAINAGE OVER PRIMARY CLOSURE OF THE COMMON BILE DUCT FOR CHOLEDOCHOLITHIASIS COMBINED WITH CHOLECYSTOLITHIASIS: A COHORT STUDY OF 211 CASES. SURG ENDOSC 31, 3219¿3226 (2017). HTTPS://DOI.ORG/10.1007/S00464-016-5348-1. INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCTS SAID TO BE INVOLVED WERE 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 PRODUCTS SAID TO BE INVOLVED WERE NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. A DEVICE FAILURE WAS NOT IDENTIFIED IN THE ARTICLE, ONLY POST PROCEDURE COMPLICATIONS. THE INSTRUCTIONS FOR USE INCLUDES POTENTIAL COMPLICATIONS: ¿THOSE ASSOCIATED WITH ERCP INCLUDE, BUT ARE NOT LIMITED TO: PANCREATITIS, CHOLANGITIS, ASPIRATION, PERFORATION, HEMORRHAGE, INFECTION, SEPSIS, ALLERGIC REACTION TO CONTRAST OR MEDICATION, HYPOTENSION, RESPIRATORY DEPRESSION OR ARREST, CARDIAC ARRHYTHMIA OR ARREST. PRIOR TO DISTRIBUTION, ALL TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOMES 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.

    Description of Event or Problem · 0

    COOK ENDOSCOPY WAS NOTIFIED OF THIS EVENT INVOLVING AN UNKNOWN NUMBER OF COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOMES. THE NUMBER OF PATIENTS INVOLVED IS EITHER TWO (2) OR THREE (3) AS THE ARTICLE IS CONFLICTING IN THE BODY OF THE ARTICLE AND IN TABLE 2 OF THE ARTICLE. PLEASE SEE BELOW FOR RELEVANT EXCERPTS OF THIS ARTICLE. "THE SURGEON STOOD IN FRONT OF THE PATIENT¿S FACE AND INSERTED THE DUODENAL ENDOSCOPE (OLYMPUS CV-260) GENTLY INTO THE PATIENT¿S DESCENDANT DUODENUM TO FIND THE BILE PAPILLA. THE BEST ANGLE IS OBTAINED BY ADJUSTING THE DUODENAL ENDOSCOPE TO ENABLE SMOOTH INSERTION OF THE PAPILLOTOME (WILSON-COOK TRI-25 M) INTO THE BILE PAPILLA. THE CONTRAST MEDIUM SHOULD BE INJECTED SLOWLY SO THAT THE ENDOSCOPIST CAN ACQUIRE A CLEAR VIEW OF THE NUMBER AND SIZE OF STONES IN THE CBD [COMMON BILE DUCT] UNDER X-RAY. A ZEBRA GUIDE WIRE (MTW-0.027) WAS INSERTED INTO THE CBD THROUGH THE PAPILLOTOME TO ENABLE THE BILE PAPILLA TO BE CUT OPEN. FOLLOWING THIS PREPARATION WORK, A BASKET (WILSON-COOK MWB3*6) OR BALLOON (WILSON-COOK TX-15-A) WAS INSERTED INTO THE CBD TO EXTRACT STONES. THIS PROCEDURE WAS REPEATED SEVERAL TIMES UNTIL STONES WERE NO LONGER OBSERVED IN THE CBD UNDER X-RAY . . .NO PATIENTS IN GROUP A DEVELOPED POSTOPERATIVE CHOLANGITIS, PANCREATITIS, JAUNDICE, OR BLEEDING. . . ANOTHER THREE (2.80%) PATIENTS IN GROUP B DEVELOPED BLEEDING AT THE SPHINCTER OF ODDI [SUBJECT OF THE REPORT]. THE BLEEDING WAS OBSERVED BY PERIPHERAL BLOOD TESTING AND A FECAL OCCULT BLOOD TEST, WHICH BECAME NEGATIVE AFTER A 1- TO 3-DAY TREATMENT WITH HEMOSTATIC DRUGS." IT WAS NOT PUBLISHED IN THE ARTICLE IF A SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE BLEEDING WAS OBSERVED BY PERIPHERAL BLOOD TESTING AND A FECAL OCCULT BLOOD TEST, WHICH BECAME NEGATIVE AFTER A 1- TO 3-DAY TREATMENT WITH HEMOSTATIC DRUGS.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: GUIDE WIRE MTW-0.027, MAKE UNKNOWN. COOK ENDOSCOPY MEMORY BASKET 7 FR HARD WIRE, MWB3X6. COOK ENDOSCOPY TRI-EX TRIPLE LUMEN EXTRACTION BALLOON TX-15-A. YIN, P., WANG, M., QIN, R. ET AL. INTRAOPERATIVE ENDOSCOPIC NASOBILIARY DRAINAGE OVER PRIMARY CLOSURE OF THE COMMON BILE DUCT FOR CHOLEDOCHOLITHIASIS COMBINED WITH CHOLECYSTOLITHIASIS: A COHORT STUDY OF 211 CASES. SURG ENDOSC 31, 3219¿3226 (2017). HTTPS://DOI.ORG/10.1007/S00464-016-5348-1. THE INVESTIGATION IS ONGOING. A FOLLOW-UP EMDR WILL BE PROVIDED WITHIN 30 DAYS OF SUBMISSION OF THIS REPORT.

    Description of Event or Problem · 1

    COOK ENDOSCOPY WAS NOTIFIED OF THIS EVENT INVOLVING THREE (3) COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. PLEASE SEE BELOW FOR RELEVANT EXCERPTS OF THIS ARTICLE. "THE SURGEON STOOD IN FRONT OF THE PATIENT¿S FACE AND INSERTED THE DUODENAL ENDOSCOPE (OLYMPUS CV-260) GENTLY INTO THE PATIENT¿S DESCENDANT DUODENUM TO FIND THE BILE PAPILLA. THE BEST ANGLE IS OBTAINED BY ADJUSTING THE DUODENAL ENDOSCOPE TO ENABLE SMOOTH INSERTION OF THE PAPILLOTOME (WILSON-COOK TRI-25 M) INTO THE BILE PAPILLA. THE CONTRAST MEDIUM SHOULD BE INJECTED SLOWLY SO THAT THE ENDOSCOPIST CAN ACQUIRE A CLEAR VIEW OF THE NUMBER AND SIZE OF STONES IN THE CBD [COMMON BILE DUCT] UNDER X-RAY. A ZEBRA GUIDE WIRE (MTW-0.027) WAS INSERTED INTO THE CBD THROUGH THE PAPILLOTOME TO ENABLE THE BILE PAPILLA TO BE CUT OPEN. FOLLOWING THIS PREPARATION WORK, A BASKET (WILSON-COOK MWB3*6) OR BALLOON (WILSON-COOK TX-15-A) WAS INSERTED INTO THE CBD TO EXTRACT STONES. THIS PROCEDURE WAS REPEATED SEVERAL TIMES UNTIL STONES WERE NO LONGER OBSERVED IN THE CBD UNDER X-RAY . . .NO PATIENTS IN GROUP A DEVELOPED POSTOPERATIVE CHOLANGITIS, PANCREATITIS, JAUNDICE, OR BLEEDING. . . ANOTHER THREE (2.80%) PATIENTS IN GROUP B DEVELOPED BLEEDING AT THE SPHINCTER OF ODDI [SUBJECT OF THE REPORT]. THE BLEEDING WAS OBSERVED BY PERIPHERAL BLOOD TESTING AND A FECAL OCCULT BLOOD TEST, WHICH BECAME NEGATIVE AFTER A 1- TO 3-DAY TREATMENT WITH HEMOSTATIC DRUGS." IT WAS NOT PUBLISHED IN THE ARTICLE IF A SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE BLEEDING WAS OBSERVED BY PERIPHERAL BLOOD TESTING AND A FECAL OCCULT BLOOD TEST, WHICH BECAME NEGATIVE AFTER A 1- TO 3-DAY TREATMENT WITH HEMOSTATIC DRUGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493666 TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS COOK ENDOSCOPY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention OLYMPUS CV-260 ENDOSCOPE| OLYMPUS CV-260 VIDEO SYSTEM AND DUODENOSCOPE