BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ELECTROSURGICAL KNIFE

    MDR report key: 14279519 · Received May 4, 2022

    Report

    Report Number
    8010047-2022-07523
    Event Type
    Injury
    Date Received
    May 4, 2022
    Date of Event
    May 17, 2019
    Report Date
    July 1, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    KNS
    UDI-DI
    04953170208409
    PMA / PMN Number
    K092309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING UPDATED TO PROVIDE ADDITIONAL INFORMATION REPORTED BY THE AUTHOR. NEW INFORMATION IS REPORTED IN B5.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED: "EVALUATING THE EFFECT OF INJECTING TRIAMCINOLONE ACETONIDE IN TWO SESSIONS FOR PREVENTING ESOPHAGEAL STRICTURE AFTER ENDOSCOPIC SUBMUCOSAL DISSECTION."     LITERATURE SUMMARY: THE STUDY INVESTIGATED THE EFFICACY OF INJECTING TRIAMCINOLONE ACETONIDE (TA) IN TWO SESSIONS FOR PREVENTING STRICTURE FORMATION POST-ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). THE PRIMARY ENDPOINT OF THIS STUDY WAS FREQUENCY OF STRICTURE AFTER TA INJECTION. THE SECONDARY ENDPOINT WAS NUMBER OF REQUIRED ENDOSCOPIC BALLOON DILATIONS (EBDS) AFTER TA INJECTION. THE POST-ESD STRICTURE RATE AMONG PATIENTS WHO HAD SUBCIRCUMFERENTIAL MUCOSAL DEFECTS WAS 45.7% IN THE STUDY GROUP (16/35 PATIENTS), WHICH WAS SIGNIFICANTLY LOWER THAN THE RATE OF 73.9% IN THE CONTROL GROUP (17/23 PATIENTS; P = 0.031). THE NUMBER OF EBD PROCEDURES REQUIRED WAS SIGNIFICANTLY LOWER IN THE STUDY GROUP (MEDIAN 0, RANGE 0 ¿ 7) THAN IN THE CONTROL GROUP (MEDIAN 4, RANGE 0 ¿ 20; P < 0.001). THIS STUDY SHOWED THAT PERFORMING TWO SESSIONS OF TA INJECTION IS AN EFFECTIVE AND SAFE TREATMENT FOR PREVENTION OF ESOPHAGEAL STRICTURE FOLLOWING SUBCIRCUMFERENTIAL ESD.     TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS. SUBCIRCUMFERENTIAL MUCOSAL DEFECTS. STUDY GROUP. PERFORATIONS AFTER EBD AT 22 AND 77 DAYS AFTER ESD - (2). CONTROL GROUP. PERFORATIONS AFTER EBD AT 36 DAYS AFTER ESD - (1). CIRCUMFERENTIAL MUCOSAL DEFECTS CONTROL GROUP. PERFORATION AFTER EBD WAS RECOGNIZED AT 7 DAYS AFTER ESD IN 1 PATIENT. THIS ARTICLE INCLUDES 4 REPORTS: (B)(6): KD-620LR. (B)(6): FD-410LR. (B)(6): GIF-Q240. (B)(6): GIF-Q260J. THIS REPORT IS 1 OF 4 FOR (B)(6): KD-620LR.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM THE AUTHOR: IN THE MEDICAL OPINION OF THE AUTHOR, THE OLYMPUS DEVICES DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENTS. THE AUTHOR STATED: ¿I DON'T KNOW IF THE POSSIBILITY IS ZERO, BUT I DON'T THINK THAT THERE IS A PROBLEM WITH THE DEVICES.¿ ADDITIONALLY, THE AUTHOR REPORTED THAT NO OLYMPUS DEVICES HAD MALFUNCTIONED DURING ANY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1593294 SINGLE USE ELECTROSURGICAL KNIFE SINGLE USE ELECTROSURGICAL KNIFE KNS OLYMPUS MEDICAL SYSTEMS CORP. KD-620LR UNKNOWN(LITERATURE) 04953170208409

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other FD-410LR,GIF-Q240 OR GIF-Q260J