BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Single Use Electrosurgical Knife

    MDR report key: 12465643 · Received September 13, 2021

    Report

    Report Number
    8010047-2021-11659
    Event Type
    Injury
    Date Received
    September 13, 2021
    Report Date
    April 16, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    KNS
    UDI-DI
    04953170208546
    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

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. CORRECTION TO G2 AND H8. 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 · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. 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.

    Description of Event or Problem · 1

    ON AUGUST 26, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE LITERATURE "EFFICACY AND SAFETY OF ENDOSCOPIC SUBMUCOSAL DISSECTION FOR GASTRIC TUBE CANCER: A MULTICENTER RETROSPECTIVE STUDY¿. THE PURPOSE OF THE LITERATURE WAS TO EVALUATE THE EFFICACY AND SAFETY OF ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) FOR GASTRIC TUBE CANCER (GTC) AFTER ESOPHAGECTOMY IN A MULTICENTER TRIAL. THE ESD WAS PERFORMED USING AN INSULATION-TIPPED DIATHERMIC KNIFE (IT KNIFE, IT KNIFE 2, IT KNIFE NANO, OR DUAL KNIFE J) AND AN ENDOSCOPE (GIF-Q260J OR GIF-H260). AN ARGON PLASMA COAGULATION PROBE FOR MARKING DOTS AND A NEEDLE KNIFE FOR THE INITIAL INCISION WERE ALSO USED BUT WERE MANUFACTURED BY NON-OLYMPUS. IN THE LITERATURE, IT WAS REPORTED ONE PATIENT OF INTRAOPERATIVE PERFORATION AS BELOW: ¿IT WAS THE SAME PATIENT WHO HAD PERFORATION DURING ESD AND WHO FORMED SUBCUTANEOUS ABSCESS AFTER ESD. IN THIS CASE, PERFORATION DURING ESD WAS SEALED IMMEDIATELY WITH ENDOCLIPS. NEVERTHELESS, 20 D AFTER ESD, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH REDNESS OF THE SKIN IN THE PRECORDIAL AREA AND EXCRETION OF PUS FROM THE SKIN. COMPUTED TOMOGRAPHY SHOWED FORMATION OF A SUBCUTANEOUS ABSCESS AROUND THE GASTRIC TUBE OF THE ANTETHORACIC RECONSTRUCTION ROUTE. THE PATIENT WAS TREATED CONSERVATIVELY WITH ANTIBIOTICS AND PERCUTANEOUS DRAINAGE AND WAS DISCHARGED ON THE 16TH DAY AFTER THE START OF RE-ADMISSION.¿ MEDICAL SAFETY OFFICERS, WHO HAVE MEDICAL DOCTOR LICENSE IN OLYMPUS, REVIEWED THE CASE OF ONE PERFORATION IN THE LITERATURE. ¿WHEN RECONSTRUCTING THE GASTRIC TUBE AFTER ESOPHAGECTOMY, THE ANASTOMOSIS BETWEEN THE ESOPHAGUS AND THE GASTRIC TUBE IS PRONE TO LEAKAGE, AND THE RECONSTRUCTION ROUTE MAY BE CHOSEN TO PLACE THE GASTRIC TUBE IN FRONT OF THE STERNUM, AS IN THIS CASE. IT WAS ESTIMATED THAT THIS CASE IS A CASE OF ESD RESECTION OF EARLY-STAGE CANCER THAT DEVELOPED IN THE GASTRIC TUBE PLACED IN FRONT OF THE STERNUM. CONSIDERING THE COURSE DESCRIBED IN THE LITERATURE, IT IS REASONABLE TO ASSUME THAT THE SUBCUTANEOUS ABSCESS IN THIS CASE WAS RELATED TO A PERFORATION DURING ESD RATHER THAN A LEAK FROM THE GASTRODUODENAL ANASTOMOSIS.¿ IT WAS ALSO REPORTED THE OTHER COMPLICATIONS; 1 INTRAOPERATIVE BLEEDING, 2 POSTOPERATIVE BLEEDINGS, 1 LIVER FAILURE, 1 RESPIRATORY FAILURE, 1 ULCERATIVE FINDING, 3 METACHRONOUS RECURRENCES, AND TWO LOCAL RECURRENCES. THESE COMPLICATIONS WERE NOT INDICATED SERIOUS INJURIES AND ASSOCIATION WITH OLYMPUS DEVICES. 10 PATIENTS DIED OF OTHER DISEASES, INCLUDING PNEUMONIA, WHICH WAS THE MOST COMMON AND OCCURRED IN 4 PATIENTS, HEART FAILURE AND HEPATOCELLULAR CARCINOMA IN 1 PATIENT EACH, AND OTHER UNKNOWN DISEASES. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE OLYMPUS PRODUCT AND THESE COMPLICATIONS COULD NOT BE DETERMINED. HOWEVER, 1 CASE OF A PERFORATION DEVELOPED A SUBCUTANEOUS ABSCESS AND REQUIRED A RE-ADMISSION AND A PROLONGED HOSPITALIZATION MIGHT BE SERIOUS INJURY, AND THE OLYMPUS KNIFE MIGHT BE USED WHEN PERFORATION OCCURRED. THIS IS THE REPORT REGARDING 1 CASE OF A PERFORATION DEVELOPED A SUBCUTANEOUS ABSCESS AND REQUIRED A RE-ADMISSION AND A PROLONGED HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1360672 Single Use Electrosurgical Knife SINGLE USE ELECTROSURGICAL KNIFE KNS OLYMPUS MEDICAL SYSTEMS CORP. KD-610L 04953170208546

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization