BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA LLL COLONOVIDEOSCOPE

    MDR report key: 14288478 · Received May 5, 2022

    Report

    Report Number
    8010047-2022-07617
    Event Type
    Injury
    Date Received
    May 5, 2022
    Date of Event
    May 28, 2019
    Report Date
    May 4, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    UDI-DI
    04953170305191
    PMA / PMN Number
    K131780
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN REPORTED BY THE IMPORTER ON MDR# 2951238 ¿ 2022- 00395. THIS REPORT IS BEING SUBMITTED TO REPORT THE USER'S EXPERIENCES AND INVESTIGATION FINDINGS. THE DEVICES REFERENCED IN THIS REPORT WERE NOT RETURNED TO OLYMPUS FOR PHYSICAL EVALUATION. THE DEVICE HISTORY RECORD (DHR) FOR THE COMPLAINT DEVICES COULD NOT BE REVIEWED SINCE THE SERIAL NUMBERS WERE NOT PROVIDED. OLYMPUS DOES NOT SHIP ANY DEVICE THAT DOES NOT MEET ALL DESIGN AND SAFETY SPECIFICATIONS. CONCLUSION: NO MALFUNCTION OF ANY OLYMPUS DEVICE WAS REPORTED IN ANY PROCEDURE DESCRIBED IN THIS ARTICLE. FROM THE INFORMATION REPORTED, IT IS PRESUMED THAT THE CAUSES OF THE REPORTED EVENTS ARE NOT DUE TO PRODUCT DEFECTS, BUT THE DEFINITIVE CAUSE COULD NOT BE ESTABLISHED.

    Description of Event or Problem · 0

    IT IS REPORTED IN THE LITERATURE TITLED ¿AN INNOVATIVE TECHNIQUE USING A PERCUTANEOUSLY PLACED GUIDEWIRE ALLOWS FOR HIGHER SUCCESS RATE FOR ERCP COMPARED TO BALLOON ENTEROSCOPY ASSISTANCE IN ROUX EN Y GASTRIC BYPASS ANATOMY,¿ PATIENTS EXPERIENCED ADVERSE EVENTS DURING OR AFTER ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURES USING OLYMPUS SCOPES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PCF-H190 USED IN PROCEDURES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS SIF-Q180 USED IN PROCEDURES. STUDY BACKGROUND/AIM: REPORT OUR RECENT EXPERIENCE USING THE WIRE-GUIDED TECHNIQUE AND TO COMPARE THE SUCCESS RATE AND ADVERSE EVENT RATE TO BAE FOR THE PERFORMANCE OF ERCP. METHODS: RETROSPECTIVE COHORT STUDY INCLUDING ALL ADULT PATIENTS WITH RYGB ANATOMY WHO UNDERWENT ERCP BETWEEN JANUARY 1, 2015, AND DECEMBER 31, 2017, AT THE MAYO CLINIC, ROCHESTER, MN. INSTITUTIONAL REVIEW BOARD APPROVAL (IRB#: 18-003419) WAS OBTAINED PRIOR TO PERFORMING THIS RETROSPECTIVE STUDY. PATIENTS WERE EXCLUDED IF THEY DID NOT HAVE RYGB ANATOMY. OTHER SURGICALLY ALTERED ANATOMY INCLUDING GASTRECTOMY, WHIPPLE, BILLROTH I/II, GASTRIC BAND, OR LIVER TRANSPLANTATION ROUX-EN-Y RECONSTRUCTION WERE ALSO EXCLUDED. BASELINE CHARACTERISTICS INCLUDING AGE, GENDER, AND BODY MASS INDEX (BMI) WERE COLLECTED FROM THE PATIENT¿S RECORDS. PROCEDURE DATA AND IMMEDIATE ADVERSE EVENTS WERE COLLECTED FROM THE ERCP ENDOSCOPY REPORTS AND ELECTRONIC MEDICAL RECORDS. DELAYED ADVERSE EVENTS WERE COLLECTED FROM THE ELECTRONIC MEDICAL RECORD THROUGH REVIEW OF SUBSEQUENT FOLLOW-UP VISITS AND PHONE CALLS DOCUMENTED BY PROVIDERS. PRIMARY OUTCOME WAS OVERALL CLINICAL SUCCESS RATE FOR EACH TECHNIQUE DEFINED AS SUCCESSFULLY REACHING THE PAPILLA, PER FORMING CHOLANGIOGRAPHY AND COMPLETING THE INTENDED THERAPEUTIC INTERVENTION OF THE PROCEDURE. DIAGNOSTIC SUCCESS WAS DEFINED AS SUCCESSFULLY OBTAINING A CHOLANGIOGRAM. SECONDARY OUTCOMES WERE MEAN PROCEDURE TIME AND ADVERSE EVENTS INCLUDING BLEEDING, PEP, AND PERFORATION. THE PROCEDURE TIME WAS DETERMINED BASED ON THE ERCP PROCEDURE TIME AND DID NOT TAKE INTO ACCOUNT INTERVENTIONAL RADIOLOGY GUIDEWIRE PLACEMENT TIME. NON-NATIVE PAPILLA WAS DEFINED AS PREVIOUSLY INCISED PAPILLA. ADVERSE EVENTS WERE DEFINED ACCORDING TO AMERICAN SOCIETY OF GASTROINTESTINAL ENDOSCOPY (ASGE) GUIDELINES [13]. BLEEDING WAS DEFINED AS HEMATEMESIS AND/OR MELENA OR HEMOGLOBIN DROP >2 G; PANCREATITIS WAS DEFINED AS TYPICAL ABDOMINAL PAIN WITH LIPASE>3 TIMES UPPER LIMIT OF NORMAL OR CROSS-SECTIONAL IMAGING DEMONSTRATING PANCREATITIS, AND PERFORATION WAS DEFINED AS EVIDENCE OF AIR OR LUMINAL CONTENTS OUTSIDE THE GI TRACT. RESULTS: WE INCLUDED 30 CONSECUTIVE PATIENTS WITH RYGB WHO UNDERWENT A TOTAL OF 62 ERCPS WITH A MEDIAN OF 1 (IQR 1¿2) PROCEDURE PER PATIENT (TABLE 1). THE MEAN AGE WAS 62.2 ±11 YEARS WITH FEMALE SEX PREDOMINANCE (83.3%). MEDIAN BMI WAS 30 KG/M2 (IQR 25¿37). EIGHT PATIENTS HAD THEIR RYGB SURGERY AT OUR INSTITUTION. AMONG THESE PATIENTS, THE LENGTH OF THE ROUX LIMB WAS EITHER 120 CM (4 PATIENTS) OR 150 CM (4 PATIENTS). THE PANCREATOBILIARY LIMB LENGTH RANGED BETWEEN 30 CM AND 60 CM FROM THE LIGAMENT OF TREITZ WITH A MEDIAN LENGTH OF 40 CM (IQR 30¿50 CM). THE LEADING INDICATIONS FOR ERCP WERE CHOLEDOCHOLITHIASIS/CHOLANGITIS 20/62 (32.3%), BENIGN BILIARY STRICTURE 7/62 (11.3%), AND BILIARY STENT EXCHANGE OR REMOVAL 13/62 (21%). THE MAJORITY OF PROCEDURES WERE PERFORMED USING BAE IN 43/62 (69.3%), FOLLOWED BY RGA IN 13/62 (21%), PERCUTANEOUS GASTROSTOMY TUBE TRACT IN THE REMNANT STOMACH IN 5/62 (8.1%), AND PEDIATRIC COLONOSCOPE IN 1/62 (1.6%). THE RGA PROCEDURE WAS PERFORMED USING A PEDIATRIC COLONOSCOPE ON TWO OCCASIONS AND WITH A SINGLE BALLOON ENTEROSCOPE IN ELEVEN. CONCLUSION: THE STUDY FOUND THAT ERCP THROUGH THE RGA APPROACH IN NATIVE PAPILLA CASES WAS HIGHLY SUCCESSFUL COMPARED TO THE BAE TECHNIQUE, WITH NO ADVERSE EVENTS RELATED TO THE PLACEMENT OR REMOVAL OF THE PERCUTANEOUS WIRE. MEAN PROCEDURE TIME WAS 33 MIN LESS WITH RGA AS COMPARED TO CLINICALLY SUCCESSFUL BAE PROCEDURES. IN THE RGA GROUP, TWO BLEEDING CASES WERE SECONDARY TO SPHINCTEROTOMY WITH >2 G DROP IN HEMOGLOBIN. THE THIRD PATIENT DEVELOPED MELENA, SYNCOPE, AND 2.5 G DROP IN HEMOGLOBIN, BUT NO BLEEDING SOURCE WAS IDENTIFIED ON REPEAT ENDOSCOPY. NONE OF THE THREE PATIENTS REQUIRED BLOOD TRANSFUSION. THERE WAS NO POST-ERCP PANCREATITIS (PEP) IN THE BAE GROUP COMPARED TO 1/13 (7.7%) IN THE RGA GROUP, P=0.4. THE ONE CASE OF PANCREATITIS WAS CLASSIFIED AS MILD AND RESOLVED WITH NO SEQUELA. ONE INTRADUCTAL GUIDEWIRE PERFORATION WAS OBSERVED IN THE BAE GROUP. THIS WAS SELF-LIMITED AND DID NOT REQUIRE ANY INTERVENTION. ONE LOCALIZED POST-SPHINCTEROTOMY PERFORATION WAS CONFIRMED ON POST-PROCEDURE COMPUTED TOMOGRAPHY (CT) IN THE RGA GROUP. THIS WAS MANAGED WITH PLACEMENT OF A TRANSHEPATIC INTERNAL/EXTERNAL PERCUTANEOUS BILIARY DRAIN OVER THE EXISTING GUIDEWIRE WHEN INITIALLY SUSPECTED AND RESOLVED WITH NO NEED FOR FURTHER INTERVENTIONS. NO ADVERSE EVENT WAS OBSERVED RELATED TO THE PERCUTANEOUS GUIDEWIRE PLACEMENT OR REMOVAL FOR THE RGA CASES. THERE IS NO REPORT OF OLYMPUS DEVICE MALFUNCTION DESCRIBED IN THIS STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1177447 EVIS EXERA LLL COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. PCF-H190L 04953170305191

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O