BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE

    MDR report key: 18426525 · Received January 2, 2024

    Report

    Report Number
    9610595-2024-00035
    Event Type
    Death
    Date Received
    January 2, 2024
    Date of Event
    September 10, 2020
    Report Date
    January 19, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDA
    UDI-DI
    04953170339943
    PMA / PMN Number
    K071254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    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. THE LITERATURE ARTICLE IS ATTACHED FOR ADDITIONAL INFORMATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL AND/OR LOT NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, THE RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENT CANNOT BE CONFIRMED. THERE WAS NO COMPLAINT REPORTED ON THE SUBJECT DEVICE. THERE IS NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. THIS SUPPLEMENTAL REPORT INCLUDES ADDITIONAL INFORMATION PROVIDED BY THE AUTHOR. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP(OMSC) RECEIVED A LITERATURE TITLED "DOES URGENT BALLOON-ASSISTED ENTEROSCOPY IMPACT REBLEEDING AND SHORT-TERM MORTALITY IN OVERT OBSCURE GASTROINTESTINAL BLEEDING?."   BACKGROUND AND AIMS: THE DIAGNOSTIC YIELD (DY) AND THERAPEUTIC YIELD (TY) OF BALLOON-ASSISTED ENTEROSCOPY (BAE) IN OVERT OBSCURE GASTROINTESTINAL BLEEDING (OGIB) IS HIGHER IN THE FIRST 72 H. THIS STUDY AIMED TO EVALUATE IF THIS HIGHER DY AND TY AFTER URGENT BAE IMPACTED THE REBLEEDING RATE, TIME TO REBLEED AND SHORT-TERM MORTALITY. METHODS: RETROSPECTIVE COHORT-STUDY, WHICH CONSECUTIVELY INCLUDED ALL PATIENTS SUBMITTED TO BAE FOR OVERT OGIB, BETWEEN 2010 AND 2019. PATIENTS WERE DISTRIBUTED IN 2 GROUPS: (1) URGENT BAE; (2) NONURGENT BAE. REBLEEDING WAS DEFINED AS AN HB DROP >2 G/DL, NEED FOR TRANSFUSIONAL SUPPORT OR PRESENCE OF MELENA/HEMATOCHEZIA. RESULTS: FIFTY-FOUR PATIENTS WERE INCLUDED, OF WHICH 17 (31.5%) WERE SUBMITTED TO BAE IN THE FIRST 72 H. DY AND TY OF URGENT BAE (DY 88.2%; N ¼ 15; TY 94.1%; N ¼ 16) WAS HIGHER COMPARED TO NON-URGENT. BAE (DY 59.5%; N ¼ 22; TY 45.9%; N ¼ 17) (DY P ¼ .03) (TY P ¼ .001). THE REBLEEDING RATE AT 1, 2, AND 5 YEARS WAS 32.0%, 34.0%AND 37.0%, RESPECTIVELY. REBLEEDING WAS LOWER AFTER URGENT BAE (17.6%; N ¼ 3) COMPARED TO NON-URGENT BAE (45.9%; N ¼ 17) (P ¼ .04). REBLEEDING TENDED TO OCCURR EARLIER IN NON-URGENT BAE, BEING AT 6-MONTHS (32.5%) AND 36 MONTHS (41.3%) (P ¼ .05). OGIB RELATED 30-DAY MORTALITY WAS 5.4% (N ¼ 2) FOR NON-URGENT BAE AND 0% FOR URGENT BAE (P ¼ .5). CONCLUSION: URGENT BAE MIGHT BE ASSOCIATED WITH HIGHER DY AND TY WITH LOWER REBLEEDING AND TREND TOWARD HIGHER REBLEEDING-FREE TIME.   TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS. 1) EVENT 1: DEATH(30-DAY MORTALITY) -2 PATIENT, 2) EVENT 2: REBLEEDING -20 PATIENTS.  THIS LITERATURE ARTICLE REQUIRES 2 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: 1) (B)(6)/SIF-Q180/DEATHS. 2) (B)(6)/SIF-Q180/REBLEEDING. THE MEDWATCH REPORT IS FOR PATIENT IDENTIFIER: OLYMPUS MEDICAL SYSTEMS CORP (OMSC) RECEIVED A LITERATURE TITLED "DOES URGENT BALLOON-ASSISTED ENTEROSCOPY IMPACT REBLEEDING AND SHORT-TERM MORTALITY IN OVERT OBSCURE GASTROINTESTINAL BLEEDING?."   BACKGROUND AND AIMS: THE DIAGNOSTIC YIELD (DY) AND THERAPEUTIC YIELD (TY) OF BALLOON-ASSISTED ENTEROSCOPY (BAE) IN OVERT OBSCURE GASTROINTESTINAL BLEEDING (OGIB) IS HIGHER IN THE FIRST 72 H. THIS STUDY AIMED TO EVALUATE IF THIS HIGHER DY AND TY AFTER URGENT BAE IMPACTED THE REBLEEDING RATE, TIME TO REBLEED AND SHORT-TERM MORTALITY. METHODS: RETROSPECTIVE COHORT-STUDY, WHICH CONSECUTIVELY INCLUDED ALL PATIENTS SUBMITTED TO BAE FOR OVERT OGIB, BETWEEN 2010 AND 2019. PATIENTS WERE DISTRIBUTED IN 2 GROUPS: (1) URGENT BAE; (2) NONURGENT BAE. REBLEEDING WAS DEFINED AS AN HB DROP >2 G/DL, NEED FOR TRANSFUSIONAL SUPPORT OR PRESENCE OF MELENA/HEMATOCHEZIA. RESULTS: FIFTY-FOUR PATIENTS WERE INCLUDED, OF WHICH 17 (31.5%) WERE SUBMITTED TO BAE IN THE FIRST 72 H. DY AND TY OF URGENT BAE (DY 88.2%; N ¼ 15; TY 94.1%; N ¼ 16) WAS HIGHER COMPARED TO NON-URGENT. BAE (DY 59.5%; N ¼ 22; TY 45.9%; N ¼ 17) (DY P ¼ .03) (TY P ¼ .001). THE REBLEEDING RATE AT 1, 2, AND 5 YEARS WAS 32.0%, 34.0%AND 37.0%, RESPECTIVELY. REBLEEDING WAS LOWER AFTER URGENT BAE (17.6%; N ¼ 3) COMPARED TO NON-URGENT BAE (45.9%; N ¼ 17) (P ¼ .04). REBLEEDING TENDED TO OCCURR EARLIER IN NON-URGENT BAE, BEING AT 6-MONTHS (32.5%) AND 36 MONTHS (41.3%) (P ¼ .05). OGIB RELATED 30-DAY MORTALITY WAS 5.4% (N ¼ 2) FOR NON-URGENT BAE AND 0% FOR URGENT BAE (P ¼ .5). CONCLUSION: URGENT BAE MIGHT BE ASSOCIATED WITH HIGHER DY AND TY WITH LOWER REBLEEDING AND TREND TOWARD HIGHER REBLEEDING-FREE TIME.   TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS. 1) EVENT 1: DEATH (30-DAY MORTALITY) -2 PATIENTS. 2) EVENT 2: REBLEEDING -20 PATIENTS.  THIS LITERATURE ARTICLE REQUIRES 2 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: 1) (B)(6)/SIF-Q180/DEATHS. 2) (B)(6)/SIF-Q180/REBLEEDING. THE MEDWATCH REPORT IS FOR PATIENT IDENTIFIER: (B)(6). THERE IS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION IN ANY PROCEDURE DESCRIBED IN THIS STUDY

    Description of Event or Problem · 0

    THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED BY THE AUTHOR: THE RESULTS PRESENTED IN THE ARTICLE ARE NOT RELATED TO THE DEVICES USED IN THE PROCEDURES. MORTALITY AND BLEEDING WERE RELATED TO THE PATIENTS' UNDERLYING PATHOLOGY AND NOT TO COMPLICATIONS ARISING FROM THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1855667 EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE SMALL INTESTINAL VIDEOSCOPE FDA AIZU OLYMPUS CO., LTD. SIF-Q180 04953170339943

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death