BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS

    MDR report key: 14856860 · Received June 29, 2022

    Report

    Report Number
    8010047-2022-11052
    Event Type
    Injury
    Date Received
    June 29, 2022
    Date of Event
    April 15, 2021
    Report Date
    August 1, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    KNS
    UDI-DI
    04953170251542
    PMA / PMN Number
    K062517
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    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 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 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. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE: "ENDOSCOPIC FULL-THICKNESS RESECTION VERSUS ENDOSCOPIC SUBMUCOSAL DISSECTION IN THE TREATMENT OF COLONIC NEOPLASTIC LESIONS = 30 MM¿A SINGLE-CENTER EXPERIENCE."    LITERATURE SUMMARY: THE PURPOSE OF THE ANALYSIS WAS TO EVALUATE EFFICACY AND SAFETY OF FULL-THICKNESS RESECTION (FTR) IN THE TREATMENT OF COLORECTAL LESIONS = 30 MM BY COMPARING PROSPECTIVELY FOLLOWED FTR COHORT TO RETROSPECTIVE SUBMUCOSAL DISSECTION (ESD) COHORT IN THE SETTING OF SINGLE TERTIARY ENDOSCOPY CENTER. PRIMARY OUTCOMES WERE TECHNICAL SUCCESS RATE, R0 RESECTION AND CURATIVE RESECTION RATE, AND COMPLICATION RATE. A TOTAL OF 52 PATIENTS IN FTR AND 50 PATIENTS IN ESD GROUP WERE TREATED BETWEEN 2015 AND 2018. TECHNICAL SUCCESS RATE WAS SIGNIFICANTLY HIGHER IN FTR GROUP (92 VS. 74%, P = 0.01) AS WELL AS R0 RESECTION RATE (85 VS. 62%, P = 0.01) AND CURATIVE RESECTION RATE (75 VS. 56%, P = 0.01). COMPLICATIONS OCCURRED MORE FREQUENTLY IN ESD GROUP (40 VS. 13%, P = 0.002), MAINLY DUE TO HIGH INCIDENCE OF ELECTROCOAGULATION SYNDROME (24 VS. 0%). TOTAL PROCEDURE TIME WAS SUBSTANTIALLY SHORTER IN FTR GROUP (26.4 ± 11.0 MIN VS. ESTIMATED 90¿240 MIN). LOCAL RESIDUAL NEOPLASTIC LESIONS WERE DETECTED NUMERICALLY MORE OFTEN IN FTR GROUP (12 VS. 5%, P = 0.12). NO PATIENT DIED DURING FOLLOW-UP. COMPARED TO ESD, FTR PROVED SIGNIFICANTLY HIGHER TECHNICAL SUCCESS RATE, HIGHER R0 AND CURATIVE RESECTION RATE, AND SHORTER PROCEDURE TIME. IN THE FTR GROUP, THERE WERE SIGNIFICANTLY LESS COMPLICATIONS BUT HIGHER INCIDENCE OF LOCAL RESIDUAL NEOPLASIA. FURTHER RESEARCH INCLUDING RANDOMIZED TRIALS IS NEEDED TO COMPARE BOTH RESECTION TECHNIQUES. PERFORATION OCCURRED IN 1 CASE IN THE FTR AND IN 4 CASES IN THE ESD GROUP. IN BOTH GROUPS, THERE WERE 4 CASES OF DELAYED BLEEDING. IN ESD GROUP, THERE WERE 20 CASES OF ELECTROCOAGULATION SYNDROME WHILE NONE IN FTR GROUP. TWO CASES OF ACUTE APPENDICITIS FOLLOWING FTR OF PERIAPPENDICULAR LESIONS WERE TREATED CONSERVATIVELY. NO PATIENT DIED DURING THIS STUDY AND FOLLOW-UP. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS FTR GROUP: PERFORATION - 1 PATIENT. DELAYED BLEEDING - 4 PATIENTS. ACUTE APPENDICITIS - 2 PATIENTS. ESD GROUP: PERFORATION - 4 PATIENTS: DELAYED BLEEDING - 4 PATIENTS: COAGULATION SYNDROME - 12 PATIENTS. THIS ARTICLE INCLUDES 8 REPORTS: (B)(6) : KD-650U - ESD ONLY GROUP ADVERSE EVENTS. (B)(6) : KD-655U - ESD ONLY GROUP ADVERSE EVENTS. (B)(6) : FD-411UR - ESD ONLY GROUP ADVERSE EVENTS. (B)(6) : HX-110UR - ESD ONLY GROUP ADVERSE EVENTS. (B)(6) : HX-201YR-135 - ESD ONLY GROUP ADVERSE EVENTS. (B)(6) : D-201-14304 - ESD ONLY GROUP ADVERSE EVENTS. (B)(6) : CF-H180AL - FOR ALL ADVERSE EVENTS. (B)(6) : CF-HQ190L - FOR ALL ADVERSE EVENTS. THIS REPORT IS 3 OF 8 FOR: (B)(6) : FD-411UR - ESD ONLY GROUP ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2253573 SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS KNS OLYMPUS MEDICAL SYSTEMS CORP. FD-411UR UNKNOWN(LITERATURE) 04953170251542

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R UNK LOT: HX-110UR OR HX-201YR-135| UNK LOT: KD-650U OR KD-655U| UNK SERIAL: (B)(6)