BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Single Use Electrosurgical Knife KD-612

    MDR report key: 13008093 · Received December 15, 2021

    Report

    Report Number
    8010047-2021-16163
    Event Type
    Injury
    Date Received
    December 15, 2021
    Report Date
    April 20, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    KNS
    UDI-DI
    04953170325892
    PMA / PMN Number
    K092309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. SINCE THE LOT NUMBER IS UNKNOWN, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. HOWEVER, OMSC HAS ONLY SHIPPED DEVICES THAT PASSED THE INSPECTION. IN THE LITERATURE, THERE WAS NO DESCRIPTION OF THE DEVICE'S MALFUNCTION.

    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

    ON (B)(6), OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE LITERATURE "A NOMOGRAM FOR PREDICTING LAPAROSCOPIC AND ENDOSCOPIC COOPERATIVE SURGERY DURING THE ENDOSCOPIC RESECTION OF SUBEPITHELIAL TUMORS OF THE UPPER GASTROINTESTINAL TRACT¿. THE PURPOSE OF THE LITERATURE WAS TO ANALYZE THE OUTCOME OF ENDOSCOPIC RESECTION FOR SUBEPITHELIAL TUMORS (SETS) AND DEVELOP A PREDICTION MODEL FOR THE NEED FOR LAPAROSCOPIC AND ENDOSCOPIC COOPERATIVE SURGERY (LECS) DURING THE PROCEDURE. THE EQUIPMENT USED FOR ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) INCLUDED OLYMPUS ENDOSCOPES (GIF-H260Z AND GIF-2TQ260M) WITH DUAL KNIFE (KD-650L; OLYMPUS MEDICAL SYSTEMS CORP., (B)(6)), IT KNIFE-2 (KD-612L; OLYMPUS), AND AN ELECTROSURGICAL GENERATOR (ESG-100; OLYMPUS). A CO2 INSUFFLATION SYSTEM (UCR; OLYMPUS) WAS USED TO REDUCE PATIENT DISCOMFORT DURING THE ESD PROCEDURE. IT WAS REPORTED THAT PREOPERATIVELY, THE AUTHORS CONSULTED THE GENERAL SURGEON ROUTINELY FOR THE POSSIBLE NEED FOR LECS IN CASES WHERE PERFORATION OCCURRED (WITH PERFORATION, THE ENDOSCOPIST COULD NOT SEAL THE SITE WITH CLIPS BECAUSE OF FULL-THICKNESS RESECTION) OR THE TUMOR WAS DEEMED UNSUITABLE FOR COMPLETE RESECTION VIA ENDOSCOPY ALONE. IN CASES INVOLVING INCIDENTAL PERFORATION OR UNCONTROLLED BLEEDING THAT COULD NOT BE RESOLVED BY ENDOSCOPIC CLIPS OR HEMOSTASIS, GENERAL SURGEONS TOOK OVER THE PROCEDURE AND COMPLETED THE PROCEDURE WITH LECS. IN THE LITERATURE, IT WAS REPORTED 17 CASES OF PERFORATION NOT REQUIRED LECS, 30 CASES OF PERFORATION REQUIRED LECS, AND 1 CASE OF DELAYED PERFORATION AS BELLOW. ¿OUT OF THE 123 PATIENTS WHO RECEIVED ENDOSCOPIC RESECTION, 47 HAD PERFORATION INTRAOPERATIVELY, AND 30 OF THEM REQUIRED LECS. MEANWHILE, ONE PATIENT HAD DELAYED PERFORATION WITH ABDOMINAL PAIN AND PNEUMOPERITONEUM SYMPTOMS AND UNDERWENT LAPAROSCOPIC SURGERY ON THE NEXT DAY AFTER ESD. LECS WAS MOST LIKELY REQUIRED IN GASTROINTESTINAL STROMAL TUMOR CASES (P = 0.0049). LESIONS LOCATED AT THE GASTRIC BODY OR FUNDUS HAD A HIGHER RATE OF LECS THAN OTHER LESION SITES ((B)(6) VS. (B)(6) , P 0.001). PERFORATION WAS UNRELATED TO TUMOR SIZE. HOWEVER, LECS WAS LIKELY REQUIRED FOR LARGER TUMORS.¿ MEDICAL SAFETY OFFICER, WHO HAVE THE MEDICAL LICENCE, REVIEWED THAT 30 CASES OF PERFORATION REQUIRED LECS ARE NOT SERIOUS INJURY, BECAUSE LECS WAS INCLUDED IN THE INTENDED PROCEDURE. BASED ON THE AVAILABLE INFORMATION, NO MALFUNCTION WAS REPORTED AND A DIRECT RELATIONSHIP BETWEEN THE OLYMPUS PRODUCT AND THESE COMPLICATIONS COULD NOT BE DETERMINED. HOWEVER, 1 CASE OF DELAYED PERFORATION REQUIRED A LAPAROSCOPIC SURGERY ON THE NEXT DAY AFTER ESD MIGHT BE SERIOUS INJURY, AND THE OLYMPUS KNIFE MIGHT BE USED WHEN PERFORATION OCCURRED. THIS IS THE REPORT REGARDING 1 CASE OF DELAYED PERFORATION REQUIRED A LAPAROSCOPIC SURGERY ON THE NEXT DAY AFTER ESD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1906052 Single Use Electrosurgical Knife KD-612 SINGLE USE ELECTROSURGICAL KNIFE KNS OLYMPUS MEDICAL SYSTEMS CORP. KD-612L 04953170325892

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention