BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE INJECTOR

    MDR report key: 14142994 · Received April 19, 2022

    Report

    Report Number
    8010047-2022-06626
    Event Type
    Injury
    Date Received
    April 19, 2022
    Date of Event
    April 17, 2019
    Report Date
    August 18, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FBK
    UDI-DI
    04953170422560
    PMA / PMN Number
    K902736
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS ONGOING. THE DEFINITIVE CAUSE OF THE USER¿S EXPERIENCE CANNOT BE DETERMINED AT THIS TIME. THIS REPORT WILL BE UPDATED UPON COMPLETION OF THE INVESTIGATION OR UPON RECEIPT OF ADDITIONAL RELEVANT INFORMATION.

    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. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT IS REPORTED IN THE LITERATURE TITLED: ¿NOVEL ENDOSCOPIC TREATMENT STRATEGY FOR EARLY ESOPHAGEAL CANCER IN CIRRHOTIC PATIENTS WITH ESOPHAGEAL VARICES,¿ THREE PATIENTS EXPERIENCED LARGE BLEEDING DURING ENDOSCOPIC MUCOSAL DISSECTION PROCEDURES USING OLYMPUS DEVICES. CASE WITH PATIENT IDENTIFIER REPORTS (B)(6) REPORTS THE NEEDLE KNIFE USED IN PATIENT PROCEDURE 3 OF 6. CASE WITH PATIENT IDENTIFIER REPORTS (B)(6) REPORTS THE KD-620LR USED IN PATIENT PROCEDURE 3 OF 6. CASE WITH PATIENT IDENTIFIER REPORTS (B)(6) REPORTS THE GF-260J USED IN PATIENT PROCEDURE 3 OF 6. CASE WITH PATIENT IDENTIFIER REPORTS (B)(6) REPORTS THE NEEDLE KNIFE USED IN PATIENT PROCEDURE 4 OF 6. CASE WITH PATIENT IDENTIFIER REPORTS (B)(6) REPORTS THE KD-620LR USED IN PATIENT PROCEDURE 4 OF 6. CASE WITH PATIENT IDENTIFIER REPORTS (B)(6) REPORTS THE GF-260J USED IN PATIENT PROCEDURE 4 OF 6. CASE WITH PATIENT IDENTIFIER REPORTS (B)(6) REPORTS THE NEEDLE KNIFE USED IN PATIENT PROCEDURE 5 OF 6. CASE WITH PATIENT IDENTIFIER REPORTS (B)(6) REPORTS THE KD-620LR USED IN PATIENT PROCEDURE 5 OF 6. CASE WITH PATIENT IDENTIFIER REPORTS (B)(6) REPORTS THE GF-260J USED IN PATIENT PROCEDURE 5 OF 6. STUDY AIM: ESTABLISH A STANDARD TREATMENT STRATEGY FOR EEC IN CIRRHOTIC PATIENTS WITH ESOPHAGEAL VARICES. METHOD: SIX CIRRHOTIC PATIENTS WITH EARLY FLAT TYPE EECS (HIGH GRADE INTRAEPITHELIAL NEOPLASIA) ON OR ADJACENT TO ESOPHAGEAL VARICES WERE ENROLLED. ESOPHAGEAL VARIX LIGATION (EVL) OR TRANS JUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) WERE USED FOR THE INITIAL MANAGEMENT OF ESOPHAGEAL VARICES. FOLLOW UP ENDOSCOPY WAS PERFORMED TWO MONTHS FOLLOWING THE INITIAL PROCEDURE. RESULTS: THE MEAN LONGITUDINAL LENGTH OF THE LESIONS WAS 4.3 CM (RANGE, 2 6 CM). THE AVERAGE PROCEDURE TIME WAS 72.8 MIN (RANGE, 34 135 MIN) AND THE AVERAGE LONGITUDINAL LENGTH OF THE RESECTED SPECIMENS WAS 45.6 MM (RANGE, 30 90 MM). ONE CASE HAD A TUMOR POSITIVE LATERAL MARGIN WITH LYMPHOVASCULAR INFILTRATION. BOTH COMPLETE AND CURATIVE RESECTION RATES WERE 80% (4/5 LESIONS). LARGE INTRAOPERATIVE BLEEDING WAS DETECTED IN PATIENTS UNDERGOING EVL COMPARED WITH TIPS PRIOR TO THE ESD PROCEDURE. NO SEVERE COMPLICATIONS OR MORTALITY ASSOCIATED EVENTS, INCLUDING MASSIVE POSTOPERATIVE BLEEDING, PERFORATION, OR HEPATIC FAILURE, WERE OBSERVED. NO RECURRENCE AND METASTASIS WERE OBSERVED DURING THE FOLLOW UP PERIOD. CONCLUSION: THE CURRENT STUDY SUGGESTED A NOVEL TREATMENT STRATEGY FOR EECS COMPLICATED BY ESOPHAGEAL VARICES IN CIRRHOSIS WITH GOOD TREATMENT RESULTS, NO NEOPLASTIC PROGRESSION AND AN ACCEPTABLE ADVERSE EVENT PROFILE. THIS STUDY INVESTIGATED A TREATMENT STRATEGY FOR EARLY ESOPHAGEAL CANCERS IN PATIENTS WITH CIRRHOSIS COMPLICATED BY ESOPHAGEAL VARICES. FOR PATIENTS UNDERGOING ESD OR RFA PROCEDURES, THE RATES OF EN BLOC AND COMPLETE RESECTIONS WERE SATISFACTORY. NO SEVERE COMPLICATIONS, INCLUDING POSTPROCEDURAL BLEEDING OR PERFORATION, OCCURRED AND THE SAFETY PROFILES WERE SATISFACTORY, SUGGESTING THAT ESD OR RFA COULD BE SAFELY APPLIED FOR THE TREATMENT OF EARLY SUPERFICIAL ESOPHAGEAL CANCER IN PATIENTS WITH CIRRHOSIS COMPLICATED BY ESOPHAGEAL VARICES. THERE IS NO REPORT OF OLYMPUS DEVICE MALFUNCTION DESCRIBED IN THIS STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2620735 SINGLE USE INJECTOR INJECTOR AND SHEATHSET FBK OLYMPUS MEDICAL SYSTEMS CORP. NM-400U-0423 UNKNOWN(LITERATURE) 04953170422560

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention| O