BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ELECTROSURGICAL KNIFE KD-655

    MDR report key: 14789516 · Received June 23, 2022

    Report

    Report Number
    8010047-2022-10681
    Event Type
    Injury
    Date Received
    June 23, 2022
    Date of Event
    February 22, 2022
    Report Date
    July 25, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    KNS
    UDI-DI
    04953170405624
    PMA / PMN Number
    K171158
    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. 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 ADDITIONAL INFORMATION FROM THE AUTHOR AND THE LEGAL MANUFACTURER'S INVESTIGATION. NEW INFORMATION ADDED TO THE FOLLOWING FIELDS: B5, H6, H10. THE DEVICE HISTORY RECORDS (DHR) FOR THIS DEVICE COULD NOT BE REVIEWED SINCE THE SERIAL NUMBER WAS NOT PROVIDED. OLYMPUS SHIPS DEVICES MANUFACTURED ACCORDING TO ALL APPLICABLE PROCEDURES AND MEET FINAL PRODUCT RELEASE CRITERIA. A DEFINITIVE ROOT CAUSE WAS NOT IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, THE LEGAL MANUFACTURER WAS UNABLE TO DETERMINE THE PROBABLE CAUSE OF THE ADVERSE EVENTS SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE: "ORIGINAL ARTICLE EFFECTS OF STEROID USE FOR STENOSIS PREVENTION AFTER ENDOSCOPIC SUBMUCOSAL DISSECTION FOR CERVICAL ESOPHAGEAL CANCER."     LITERATURE SUMMARY ESOPHAGEAL STENOSIS IS A SERIOUS COMPLICATION AFTER ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) FOR THORACIC ESOPHAGEAL CANCER (TEC), AND STEROID HAS BEEN APPLIED FOR STENOSIS PREVENTION. HOWEVER, THE RATE OF STENOSIS AND EFFECT OF STEROID FOR ESD OF CERVICAL ESOPHAGEAL CANCER (CEC) REMAIN UNKNOWN. THE AIM WAS TO CLARIFY THE RATE AND MANAGEMENTS OF POST-ESD STENOSIS FOR CEC.     TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS. MUSCLE INJURY DURING ESD IN TEC GROUP -(14). POST ESD BLEEDING - (2). PERFORATION - (9). POST ESD STRICTURE - (24). ASPIRATION PNEUMONIA - (2). ADDITIONAL TREATMENT AFTER ESD (SURGERY - 10, CRT - 9). THIS ARTICLE INCLUDES 3 REPORTS: (B)(6): GIF-Q260J. (B)(6): GIF-H290T. (B)(6): KD-655L. THIS REPORT IS 3 OF 3 FOR (B)(6): KD-655L. THE AUTHORS USED DUAL KNIFE J. KD-655L IS BEING USED AS A REPRESENTATIVE PRODUCT.

    Description of Event or Problem · 0

    THE AUTHOR RESPONDED TO OUR REQUEST FOR ADDITIONAL INFORMATION. THE AUTHOR DID NOT HAVE THE MODEL SERIAL OR LOT NUMBERS AVAILABLE. THE AUTHOR CONFIRMED NO MALFUNCTIONS OCCURRED WITH OLYMPUS DEVICES. IN THE OPINION OF THE AUTHOR, THE OLYMPUS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331888 SINGLE USE ELECTROSURGICAL KNIFE KD-655 SINGLE USE ELECTROSURGICAL KNIFE KNS OLYMPUS MEDICAL SYSTEMS CORP. KD-655L UNKNOWN(LITERATURE) 04953170405624

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other UNK SERIAL: GIF-Q260J,GIF-H290T.