BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE DISTAL ATTACHMENT

    MDR report key: 20215580 · Received September 13, 2024

    Report

    Report Number
    9614641-2024-01826
    Event Type
    Injury
    Date Received
    September 13, 2024
    Date of Event
    May 23, 2024
    Report Date
    December 2, 2024
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    FDS
    UDI-DI
    04953170453847
    PMA / PMN Number
    K984358
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIERS: (B)(6). THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND TO PROVIDE A CORRECTION TO THE INITIAL WITH INFORMATION INADVERTENTLY LEFT OUT (B5). 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, IT IS LIKELY THAT THE REPORTED EVENT IS AN ACCIDENT, OR A COMPLICATION ASSOCIATED WITH A PROCEDURE USING THE SUBJECT DEVICE. 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. 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 "RISK FACTORS AND A NOMOGRAM FOR PREDICTION OF POST-ENDOSCOPIC SUBMUCOSAL DISSECTION ELECTROCOAGULATION SYNDROME FOR SUPERFICIAL COLORECTAL LESIONS". LITERATURE SUMMARY. BACKGROUND POST-ENDOSCOPIC SUBMUCOSAL DISSECTION ELECTROCOAGULATION SYNDROME (PEECS) IS AN UNCOMMON COMPLICATION AFTER COLORECTAL ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). THIS STUDY AIMED TO EXPLORE THE RISK FACTORS OF PEECS FOR SUPERFICIAL COLORECTAL LESIONS BASED ON THE LATEST AND CONSISTENT DIAGNOSTIC CRITERIA AND TO ESTABLISH A PREDICTIVE NOMOGRAM MODEL. METHODS: THIS RETROSPECTIVE ANALYSIS INCLUDED PATIENTS WITH SUPERFICIAL COLORECTAL LESIONS WHO UNDERWENT ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) BETWEEN JUNE 2008 AND DECEMBER 2021 IN OUR CENTER. THE INDEPENDENT RISK FACTORS OF PEECS FOR SUPERFICIAL COLORECTAL LESIONS WERE IDENTIFIED USING LEAST ABSOLUTE SHRINKAGE AND SELECTION OPERATOR (LASSO) LOGISTIC REGRESSION ANALYSIS, AS WELL AS UNIVARIATE ANALYSIS AND MULTIVARIATE LOGISTIC REGRESSION, AND DERIVED PREDICTIVE NOMOGRAM MODEL WAS CONSTRUCTED. RESULTS: AMONG THE 555 PATIENTS WITH SUPERFICIAL COLORECTAL LESIONS ENROLLED, PEECS OCCURRED IN 45 (8.1%) PATIENTS. MULTIVARIATE LOGISTIC REGRESSION REVEALED THAT FEMALE SEX (OR 3.94, P < 0.001), AGE > 50 YEARS (OR 4.28, P = 0.02), INJURY TO MUSCLE LAYER (OR 10.38, P < 0.001), NON-LIFTING SIGN (OR 2.20, P = 0.04) AND INADEQUATE BOWEL PREPARATION (OR 5.61, P < 0.001) WERE INDEPENDENT RISK FACTORS OF PEECS FOR SUPERFICIAL COLORECTAL LESIONS. A PREDICTIVE NOMOGRAM MODEL WAS CONSTRUCTED BASED ON THE ABOVE FIVE PREDICTORS. FOR THIS MODEL, THE AREA UNDER THE RECEIVER OPERATING CHARACTERISTIC (ROC) CURVE WAS 0.855, THE CALIBRATION CURVE EXHIBITED GOOD CONSISTENCY BETWEEN THE PREDICTION AND THE ACTUAL OBSERVATION, AND THE C-INDEX WAS CONFIRMED AS 0.843 BY BOOTSTRAP METHOD. CONCLUSION: FEMALE SEX, AGE > 50 YEARS, INJURY TO MUSCLE LAYER, NON-LIFTING SIGN AND INADEQUATE BOWEL PREPARATION WERE INDEPENDENT RISK FACTORS OF PEECS FOR SUPERFICIAL COLORECTAL LESIONS. THE PROPOSED NOMOGRAM COULD ACCURATELY PREDICT THE RISK OF PEECS FOR SUPERFICIAL COLORECTAL LESIONS. ¿TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS. INTRAOPERATIVE PERFORATION (72) DELAYED PERFORATION (3) INTRAOPERATIVE BLEEDING (280) DELAYED BLEEDING (36) POSTOPERATIVE FEVER (166) POST-ENDOSCOPIC SUBMUCOSAL DISSECTION ELECTROCOAGULATION SYNDROME (45) POSTOPERATIVE FEVER (127) LOCALIZED ABDOMINAL PAIN OR TENDERNESS (45) FEVER (39) INFLAMMATORY RESPONSE (27).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED FROM THE CUSTOMER. HOWEVER, THE CUSTOMER CONFIRMED THAT THEY DO NOT KNOW THE CIRCUMSTANCES AROUND THIS SPECIFIC SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1112031 DISPOSABLE DISTAL ATTACHMENT DISPOSABLE DISTAL ATTACHMENT FDS AOMORI OLYMPUS CO., LTD. D-201-11802 04953170453847

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention ELECTROSURGICAL KNIFE, KD-655Q, SN-UNK| GASTROVIDEOSCOPE, GIF-Q260J, SN-UNK| HEMOSTATIC GRASPER, FD-411QR, SN-UNK| HOOKKNIFE ELECTROSURGICAL KNIFE, KD-620QR, SN-UNK