BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE DISTAL ATTACHMENT

    MDR report key: 13760368 · Received March 14, 2022

    Report

    Report Number
    8010047-2022-04389
    Event Type
    Injury
    Date Received
    March 14, 2022
    Report Date
    April 18, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    UDI-DI
    04953170278280
    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

    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 SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER¿S INVESTIGATION AND RESPONSE FROM THE AUTHOR. NEW INFORMATION ADDED TO: B5, D10, H6, H10. DEVICE HISTORY RECORDS REVIEW WAS NOT PERFORMED SINCE THE SERIAL NUMBER WAS NOT PROVIDED. OLYMPUS SHIPS PRODUCT MANUFACTURED ACCORDING TO ALL APPLICABLE PROCEDURES AND MEET FINAL PRODUCT RELEASE CRITERIA. A DEFINITIVE ROOT CAUSE WAS NOT IDENTIFIED.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED A LITERATURE TITLED "THE VALUE OF ENDOSCOPIC ULTRASONOGRAPHY IN THE ENDOSCOPIC RESECTION OF GASTROINTESTINAL STROMAL TUMORS". THIS RETROSPECTIVE, SINGLE-CENTER STUDY WAS AIMED TO EXPLORE THE CLINICAL VALUE OF ENDOSCOPIC ULTRASONOGRAPHY (EUS) IN THE ENDOSCOPIC RESECTION OF GASTROINTESTINAL STROMAL TUMORS (GISTS). A TOTAL OF 92 PATIENTS WERE INCLUDED WERE UNDERWENT ENDOSCOPIC TREATMENT, OF WHICH 89 (96.7%) PATIENTS UNDERWENT COMPLETE PATHOLOGICAL RESECTION. OF THESE 92 PATIENTS, 37 (40.2%) UNDERWENT ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD), 27 (29.4%) UNDERWENT ENDOSCOPIC SUBMUCOSAL EXCAVATION (ESE), 15 (16.3%) UNDERWENT ENDOSCOPIC FULL-THICKNESS RESECTION (EFTR), NINE (9.8%) UNDERWENT ENDOSCOPIC BAND LIGATION (EBL), AND FOUR (4.3%) UNDERWENT SUBMUCOSAL TUNNELING ENDOSCOPIC RESECTION (STER). THE STUDY REPORTED A 78.7% RATE FOR PREOPERATIVE DIAGNOSIS RATE OF EUS AND POSTOPERATIVE PATHOLOGICAL DIAGNOSIS OF GISTS. THE PRESENCE OF A NON-HOMOGENEOUS ECHO AND LIQUID ANECHOIC ZONE IN GISTS OFTEN INDICATED HIGHER RISK (P < 0.05). THE STUDY CONCLUDED THAT ENDOSCOPIC RESECTION OF GISTS IS FEASIBLE AND SAFE. EUS IS OF GREAT SIGNIFICANCE FOR THE DIAGNOSIS AND RISK ASSESSMENT OF GISTS AND CAN ASSIST IN THE ENDOSCOPIC RESECTION OF GISTS. COMPLICATIONS: INTRAOPERATIVE BLEEDING OCCURRED IN TWO PATIENTS (2.2%), AND BOTH OF THESE CASES OCCURRED DURING ESE. THERMAL BIOPSY FORCEPS AND TITANIUM CLAMPS WERE SUCCESSFULLY USED TO STOP THE BLEEDING. PERFORATION OCCURRED IN 13 PATIENTS (14.1%; CASES OF PERFORATION DURING EFTR WERE NOT INCLUDED), THREE OF WHICH OCCURRED DURING EBL, SIX DURING ESD, AND FOUR DURING ESE. THESE PERFORATIONS WERE SUCCESSFULLY CLOSED WITH TITANIUM CLIPS, TITANIUM CLIPS COMBINED WITH A PURSE-STRING SUTURE, OR OTSCS®. AFTER THE PROCEDURE, ELECTROCOAGULATION SYNDROME OCCURRED IN SEVEN PATIENTS (TWO CASES AFTER ESD, TWO AFTER ESE, AND THREE AFTER EFTR). ALL THE PATIENTS IMPROVED AFTER CONSERVATIVE TREATMENTS, SUCH AS THE DEPRIVATION OF FOOD AND WATER, REHYDRATION, OR RATIONAL INTRAVENOUS USE OF ANTIBIOTICS. POSTOPERATIVE PERFORATION OCCURRED IN ONE PATIENT UNDERGOING ESD, AND THE PATIENT IMPROVED AFTER SURGERY. THE AUTHORS USED 4 OLYMPUS DEVICES: DUAL-KNIFE (KD-655L OR KD-655Q), IT-KNIFE (KD-612L), AND AND HYALINE CAP (D-201-11804); AND REPORTED THE FOLLOWING ADVERSE EVENTS: ADVERSE EVENTS (NUMBER OF PATIENTS): INTRAOPERATIVE BLEEDING - (2). INTRAOPERATIVE PERFORATION - (13). POSTOPERATIVE PERFORATION - (1). POSTOPERATIVE COAGULATION SYNDROME - (7). THIS ARTICLE INCLUDES 3 REPORTS: (B)(6): KD-612L. (B)(6): KD-655L OR KD-655Q. (B)(6): D-201-11804. THIS REPORT IS 3 OF 3 FOR (B)(6)

    Description of Event or Problem · 0

    THE AUTHOR PROVIDED ADDITIONAL INFORMATION: THE AUTHOR STATED, IN HIS MEDICAL OPINION, NO ADVERSE EVENTS WERE LINKED TO OLYMPUS PRODUCTS IN THE STUDY. THE AUTHOR ALSO STATED THE FOLLOWING ADDITIONAL DEVICES WERE USED IN THE STUDY: GIF-Q260J, CLV-290SL, CV-290. THIS ARTICLE INCLUDES 4 REPORTS: (B)(6): KD-612L. (B)(6): KD-655L OR KD-655Q. (B)(6): D-201-11804. (B)(6): GIF-Q260J. THIS IS 3 OF 4: (B)(6): D-201-11804.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282734 DISPOSABLE DISTAL ATTACHMENT DISPOSABLE DISTAL ATTACHMENT FDS OLYMPUS MEDICAL SYSTEMS CORP. D-201-11804 UNKNOWN(LITERATURE) 04953170278280

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R GIF-Q260J,CLV-290SL,CV-290| KD-612L, AND/OR KD-655L OR KD-655Q