BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS

    MDR report key: 16400755 · Received February 17, 2023

    Report

    Report Number
    9614641-2023-00243
    Event Type
    Injury
    Date Received
    February 17, 2023
    Date of Event
    January 21, 2021
    Report Date
    March 15, 2023
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    KNS
    UDI-DI
    04953170251542
    PMA / PMN Number
    K062517
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 INFORMATION ADDED TO B5 AND D9. ALSO, A CORRECTION HAS BEEN MADE TO E1 FROM THE INITIAL MEDWATCH. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE SUSPECT DEVICE IS UNKNOWN. THE DEVICE WILL NOT BE RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROGRESS. THE LITERATURE ARTICLE IS ATTACHED FOR ADDITIONAL INFORMATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS RECEIVED: THE AUTHORS DECLARE THAT THEY HAVE NOTHING TO DISCLOSE.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED ¿HISTOPATHOLOGIC DIAGNOSIS DISCREPANCIES BETWEEN PREOPERATIVE ENDOSCOPIC FORCEPS BIOPSIES AND SPECIMENS RESECTED BY ENDOSCOPIC SUBMUCOSAL DISSECTION IN SUPERFICIAL GASTRIC NEOPLASMS¿. BACKGROUND: THE STANDARD OF PRACTICE WHEN A SUPERFICIAL LESION WAS IDENTIFIED DURING UPPER GI ENDOSCOPY IS TO TAKE AN ENDOSCOPIC FORCEPS BIOPSY (EFB) OF THE LESION. THE HISTOPATHOLOGIC FINDINGS THEN WILL DETERMINE THE MANAGEMENT PLAN. ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) ENABLES EN-BLOC RESECTION FOR EARLY NEOPLASMS OF THE GASTROINTESTINAL TRACT AND PROVIDES AN ADEQUATE SPECIMEN THAT PERMITS A MORE RELIABLE HISTOPATHOLOGIC ASSESSMENT. THE OBJECTIVE OF THIS STUDY WAS TO DETERMINE THE RATE OF HISTOPATHOLOGIC DISCREPANCY BETWEEN EFB AND SPECIMENS RESECTED BY ESD, AND TO IDENTIFY THE PREDISPOSING RISK FACTORS FOR THIS DISCORDANCE. MATERIALS AND METHODS: THIS IS A RETROSPECTIVE STUDY, ENROLLING PATIENTS WITH SUPERFICIAL GASTRIC NEOPLASMS THAT UNDERWENT EFB FOLLOWED BY ESD. WE DIVIDED CASES TO CONCORDANT OR DISCORDANT GROUP ACCORDING TO THE HISTOPATHOLOGIC DIAGNOSIS OF EFB AND ESD SPECIMENS. WE ALSO ANALYZED THE FEATURES THAT MAY HAVE INFLUENCED THE OCCURRENCE OF HISTOPATHOLOGIC DISCORDANCE AND THE ASSOCIATION BETWEEN DISCORDANT SAMPLES OF ADENOCARCINOMA AND NEOPLASTIC INVASION TO DEEPER LAYERS. RESULTS: A TOTAL OF 115 GASTRIC ESD PROCEDURES WERE PERFORMED WITH 84 PATIENTS MEETING THE INCLUSION CRITERIA. HISTOPATHOLOGIC DISCORDANCE BETWEEN EFB AND ESD SPECIMENS WERE OBSERVED IN 35.8% OF CASES (30/84 LESIONS). THE UNIVARIANT-BIVARIANT ANALYSIS AND MULTIVARIATE LOGISTIC REGRESSION ANALYSIS SHOWED THAT HISTOLOGIC DISCORDANCE WAS CLOSELY RELATED TO THE SIZE OF THE LESIONS (P =0.028). CONCLUSIONS : HISTOPATHOLOGIC DISCREPANCY BETWEEN EFB AND ESD SPECIMENS MAY OCCUR IN APPROXIMATELY ONE-THIRD OF CASES, PARTICULARLY FOR LESIONS OVER 20 MM, WHICH MAY LEAD TO CRUCIAL DELAYS IN GASTRIC CANCER PRECISE DIAGNOSIS AND TREATMENT. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: LATE GASTROINTESTINAL BLEEDING: 2; THERE ARE TWO REPORTS OF COMPLICATIONS THAT INCLUDE TWO PATIENTS WITH REPORTED LATE GASTROINTESTINAL BLEEDING. THERE IS NO REPORT OF AN OLYMPUS DEVICE MALFUNCTION REPORTED IN THE PROCEDURES DESCRIBED IN THIS STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655946 SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS KNS AOMORI OLYMPUS CO., LTD. FD-411UR LITERATURE (NO SERIAL) 04953170251542

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other