BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE

    MDR report key: 14828492 · Received June 27, 2022

    Report

    Report Number
    8010047-2022-10832
    Event Type
    Injury
    Date Received
    June 27, 2022
    Report Date
    August 5, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDA
    UDI-DI
    04953170339943
    PMA / PMN Number
    K071254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION FROM THE AUTHOR AND THE LEGAL MANUFACTURER'S INVESTIGATION. THE DEVICE HISTORY RECORDS (DHR) FOR THIS DEVICE COULD NOT BE REVIEWED SINCE THE SERIAL NUMBER WAS NOT PROVIDED. OLYMPUS SHIPS DEVICES MANUFACTURED ACCORDING TO ALL APPLICABLE PROCEDURES AND MEET FINAL PRODUCT RELEASE CRITERIA. A DEFINITIVE ROOT CAUSE WAS NOT IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, THE LEGAL MANUFACTURER WAS UNABLE TO DETERMINE THE PROBABLE CAUSE OF THE ADVERSE EVENTS SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO MALFUNCTIONS WERE REPORTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "COMPARISON OF DOUBLE-BALLOON AND SINGLE-BALLOON ENTEROSCOPE FOR THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOGRAPHY AFTER ROUX-EN-Y SMALL BOWEL SURGERY". LITERATURE SUMMARY: THE OBJECTIVE OF THE CURRENT STUDY IS TO COMPARE SUCCESS AND COMPLICATION RATE OF DOUBLE-BALLOON (DBE) AND SINGLE-BALLOON ENTEROSCOPE (SBE) TO PERFORM ERCP IN ROUX-EN-Y PATIENTS. MALE-FEMALE RATIO WAS 28/45 WITH A MEAN AGE OF 58 ± 2 YEARS. 30 (32 %) PROCEDURES WERE PERFORMED WITH DBE AND 65 (68 %) WITH SBE. OVERALL ERCP SUCCESS RATE WAS 73 % FOR DBE AND 75 % FOR SBE (P = 0.831). FAILURE WAS DUE TO INABILITY TO REACH OR CANNULATE THE INTACT PAPILLA OR BILIOENTERIC ANASTOMOSIS. SUCCESS RATE WAS SIGNIFICANTLY HIGHER WHEN PERFORMED AT THE BILIOENTERIC ANASTOMOSIS (80 % SUCCESS IN 56 PROCEDURES) OR AT THE INTACT PAPILLA IN SHORT-LIMB ROUX-EN-Y (80 % IN 15 PROCEDURES) AS COMPARED TO THE INTACT PAPILLA IN LONG-LIMB (58 % IN 24 PROCEDURES; P = 0.040). ADVERSE EVENT RATES WERE 10 % (DBE) AND 8 % (SBE) (P = 0.707) AND MOSTLY DEALT WITH CONSERVATIVELY. ERCP AFTER ROUX-EN-Y ALTERED SMALL BOWEL ANATOMY IS FEASIBLE AND SAFE USING BOTH DBE AND SBE. BOTH TECHNIQUES ARE EQUALLY COMPETENT WITH HIGH SUCCESS RATES AND ACCEPTABLE ADVERSE EVENTS RATES. ERCP AT THE LEVEL OF THE INTACT PAPILLA IN LONG LIMB ROUX-EN-Y IS LESS SUCCESSFUL AS COMPARED TO SHORT-LIMB OR BILIOENTERIC ANASTOMOSIS. SERIOUS ADVERSE EVENTS OCCURRED IN 8 PROCEDURES, 3/30 WITH DBE (10 %) AND 5/65 WITH SBE (8 %) (P = 0.704). THERE WERE 3 CASES OF RETROPERITONEAL FREE AIR AFTER SPHINCTEROTOMY AND SPHINCTEROPLASTY WHICH WERE ALL TREATED CONSERVATIVELY BY MEANS OF INTRAVENOUS ANTIBIOTICS AND IN 1 CASE INTRAVENOUS SOMATOSTATIN. THERE WERE 2 CASES OF POST-ERCP CHOLANGITIS WHICH WERE TREATED WITH INTRAVENOUS ANTIBIOTICS AND 2 WITH POST-ERCP PANCREATITIS WITH NORMAL OUTCOME AFTER CONSERVATIVE TREATMENT. FINALLY, 1 CASE OF LIVER CAPSULA DEHISCENCE BECAUSE OF GUIDE WIRE PERFORATION RESULTED IN SURINFECTED SUBCAPSULAR LIVER HEMATOMA AND NEEDED SURGICAL DRAINAGE. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: RETROPERITONEAL FREE AIR AFTER SPHICTEROTOMY AND SPHINCTEROPLASTY -(3). POST-ERCP CHOLANGITIS -(2). POST-ERCP PANCREATITIS -(2). LIVER CAPSULA DEHISCENCE -(1). THIS ARTICLE INCLUDES TWO REPORTS: (B)(6) :FOR OTHER PATIENTS. (B)(6) :FOR AN 81-YEAR-OLD MALE PATIENT - LIVER CAPSULA DEHISCENCE. THIS REPORT IS 1 OF 2 FOR (B)(6) :FOR OTHER PATIENTS.

    Description of Event or Problem · 0

    THE AUTHOR REPORTED ADDITIONAL INFORMATION: THE LOT AND SERIAL NUMBERS FOR THE OLYMPUS DEVICES ARE NOT AVAILABLE AND THEY ARE NOT AVAILABLE FOR RETURN. THE AUTHOR REPORTED AN ADDITIONAL ADVERSE EVENT OF RETROPERITONEAL FREE AIR AFTER SPHINCTEROTOMY AND SPHINCTEROPLASTY IN THREE (3) PATIENTS WHICH DID NOT REQUIRE TREATMENT OR INTERVENTION. THE AUTHOR CONFIRMED NO OLYMPUS DEVICE MALFUNCTIONS. THE AUTHOR REPORTED ADDITIONAL INFORMATION SPECIFIC TO THE LIVER DEHISCENCE STARTING IN ORDER TO ADVANCE THE ENDOSCOPE, BUT ALSO TO STABILIZE THE ENDOSCOPE DURING THE ERCP-PART OF THE PROCEDURE, THE BALLOON IS INFLATED, THEREBY CLOSING THE AFFERENT LOOP. THIS CAN LEAD TO INCREASED INTRALUMINAL AND INTRADUCTAL PRESSURE, WHICH CAN LEAD TO RETROPERITONEAL FREE AIR. THIS COULD ALSO HAVE CAUSED THE LIVER CAPSULA DEHISCENCE IN THE LAST PATIENT, AFTER HAVING INTRODUCED THE GUIDEWIRE DEEPER IN THE INTRAHEPATIC BILIARY TRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    932672 EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE SMALL INTESTINAL VIDEOSCOPE FDA OLYMPUS MEDICAL SYSTEMS CORP. SIF-Q180 04953170339943

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R OLYMPUS PROTOTYPES: GUIDEWIRE G-Y0001| OLYMPUS PROTOTYPES: STENT PUSHER MAJ-Y0025-1| OLYMPUS PROTOTYPES: CANNULATION CATHETER PR-Y0001| OLYMPUS PROTOTYPES: EXTRACTION BALLOON B-Y0003| OLYMPUS PROTOTYPES: NEEDLE KNIFE KD-Y0001| OLYMPUS PROTOTYPES: RETRIEVAL BASKET FG-Y0003| OLYMPUS PROTOTYPES: SPHINCTEROTOME KD-Y0005