BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSCOPIC CO2 REGULATION UNIT

    MDR report key: 14103865 · Received April 13, 2022

    Report

    Report Number
    8010047-2022-06215
    Event Type
    Injury
    Date Received
    April 13, 2022
    Report Date
    June 22, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    HIF
    UDI-DI
    04953170239113
    PMA / PMN Number
    K081173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. NEW INFORMATION ADDED TO B5.

    Additional Manufacturer Narrative · 0

    THIS IS A SUPPLEMENTAL REPORT TO CORRECT THE INITIAL MDR. AFTER RECEIVING ADDITIONAL INFORMATION FROM THE AUTHOR, THE ADVERSE EVENTS HAVE BEEN REVIEWED BY THE LEGAL MANUFACTURER AND IT HAS BEEN DETERMINED THE EVENTS ARE NOT A SERIOUS INJURY.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE ARTICLE: "PROPENSITY SCORE MATCHING ANALYSIS TO EVALUATE EFFICACY OF POLYETHYLENE OXIDE ADHESIVE ON PREVENTING DELAYED BLEEDING AFTER GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION" BY YANG YU, ET AL.   REGARDLESS OF TECHNICAL ADVANCEMENTS, DELAYED BLEEDING IS STILL A COMMON ADVERSE EVENT AFTER GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD), OFTEN OCCURRING IN THE EARLY POSTOPERATIVE PHASE. THIS STUDY AIMED TO EVALUATE THE EFFICACY OF A NEWLY DESIGNED POLYETHYLENE OXIDE (PEO) ADHESIVE FOR PREVENTING DELAYED GASTRIC BLEEDING. PATIENTS WHO UNDERWENT GASTRIC ESD BETWEEN DECEMBER 2017 AND DECEMBER 2020 AT THREE CHINESE INSTITUTIONS WERE RETROSPECTIVELY REVIEWED. PATIENTS RECEIVING PEO APPLICATION ON GASTRIC POST-ESD ULCERS WERE INCLUDED IN THE PEO GROUP, AND PATIENTS WITHOUT THIS PROCEDURE WERE INCLUDED IN THE CONTROL GROUP. TO MINIMIZE POTENTIAL BIAS, PROPENSITY SCORE MATCHING WAS PERFORMED, AND SEX, AGE, LESION SIZE, LESION MORPHOLOGY, ULCERATION, LOCALIZATION, PROCEDURE TIME, FREQUENCY OF MAJOR INTRAOPERATIVE BLEEDING, RESECTED SPECIMEN SIZE, LESION HISTOPATHOLOGY, SUBMUCOSAL INVASION AND THE TAKING OF ANTITHROMBOTIC DRUGS WERE INCLUDED AS MATCHING FACTORS. THE INCIDENCE OF DELAYED BLEEDING AND TIME TO BLEEDING WERE COMPARED BETWEEN BOTH GROUPS. AFTER PROPENSITY SCORE MATCHING, 270 PATIENTS (135 PER GROUP) WERE INCLUDED IN THE ANALYSIS. THE DELAYED BLEEDING RATE IN THE PEO GROUP WAS SIGNIFICANTLY LOWER THAN THAT IN THE CONTROL GROUP (1.5%, 2/135 VS. 8.9%, 12/135, P= 0.006). THE MEDIAN TIME (RANGE) TO BLEEDING WAS 4.5 (4¿5) DAYS IN THE PEO GROUP AND 2 (1¿15) DAYS IN THE CONTROL GROUP, WITH NO SIGNIFICANT DIFFERENCE (P= 0. 198). PEO DEMONSTRATED A SIGNIFICANT EFFECT IN REDUCING THE RATE OF DELAYED BLEEDING. FURTHER STUDY IS WARRANTED TO CONFIRM THE EFFICACY OF PEO FOR BLEEDING THAT OCCURS IN THE EARLY PHASE AFTER GASTRIC ESD. ADVERSE EVENTS: N = 1 EXPERIENCED HAEMORRHAGIC SHOCK ON POD1 WITH TRANSIENT TACHYCARDIA AND HYPOTENSION, AND HE ALSO RECEIVED A BLOOD TRANSFUSION BECAUSE OF A DECREASE IN HAEMOGLOBIN FROM 101 TO 62 G/L. AFTER ENDOSCOPIC HAEMOSTASIS AND CONVENTIONAL MEDICAL TREATMENT, THE PATIENT¿S CONDITION STABILIZED ON THE SAME DAY, AND HE WAS DISCHARGED ON N = >14 - FOR PATIENTS WITH DELAYED BLEEDING, ENDOSCOPIC HAEMOSTASIS WAS SUCCESSFULLY PERFORMED PRIMARILY WITH ELECTROCOAGULATION FOR ALL BLEEDING SITES. METAL CLIPS WERE USED AS COMBINED THERAPY FOR 5 LESIONS. IMMEDIATE HAEMOSTASIS WAS ACHIEVED IN ALL CASES, AND NO RE-BLEEDING EVENTS OCCURRED LATER. N= 4: MAJOR INTRAOPERATIVE BLEEDING WAS ARTERIOLAR BLEEDING OR DIFFUSE VENOUS BLEEDING IN WHICH HAEMORRHAGIC SITES COULD NOT BE LOCATED FOR THE FIRST TIME. THE ARTICLE INCLUDES 6 REPORTS: PATIENT IDENTIFIER (B)(6) KD-650U, PATIENT IDENTIFIER (B)(6) GIF-HQ290, PATIENT IDENTIFIER (B)(6) UCR, PATIENT IDENTIFIER (B)(6) FD-411UR, PATIENT IDENTIFIER (B)(6) NM-200L-0423, PATIENT IDENTIFIER (B)(6) GIF-Q260J. THIS REPORT IS 3 OF 6 FOR PATIENT IDENTIFIER (B)(6) UCR.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM THE AUTHOR: THE AUTHOR STATED THE OLYMPUS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENTS REPORTED. HE ALSO REPORTED: THE IMAGE BLURRING DURING THE OPERATION HAD NOTHING TO DO WITH OUR MACHINE. THE HAEMOSTATIC POWDER USED IN THE LITERATURE WAS STICKY, WHICH STUCK TO THE CCD GLASS OF OUR ENDOSCOPE DURING ESD SURGERY, CAUSING TEMPORARY IMAGE BLURRING. THESE PROBLEMS WERE DETERMINED BY THE HAEMOSTATIC POWDER PROVIDED BY OTHER MANUFACTURERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2669365 ENDOSCOPIC CO2 REGULATION UNIT CO2 REGULATION UNIT HIF OLYMPUS MEDICAL SYSTEMS CORP. UCR 04953170239113

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O SERIAL/LOTS UNKNOWN: KD-650U,GIF-HQ290,FD-411UR,| SERIAL/LOTS UNKNOWN:NM-200L-0423,GIF-Q260J