BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ELECTROSURGICAL KNIFE KD-650

    MDR report key: 14401178 · Received May 13, 2022

    Report

    Report Number
    8010047-2022-08240
    Event Type
    Injury
    Date Received
    May 13, 2022
    Date of Event
    December 6, 2021
    Report Date
    October 26, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    KNS
    UDI-DI
    04953170265761
    PMA / PMN Number
    K092309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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 SERIAL AND/OR 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. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "BENEFIT OF RADIOFREQUENCY ABLATION AFTER WIDESPREAD ENDOSCOPIC RESECTION OF NEOPLASTIC BARRETT¿S ESOPHAGUS IN DAILY PRACTICE". LITERATURE SUMMARY: THIS RETROSPECTIVE STUDY DESCRIBED THE BENEFIT OF RADIOFREQUENCY ABLATION AFTER WIDESPREAD ENDOSCOPIC RESECTION OF NEOPLASTIC BARRETT¿S ESOPHAGUS IN DAILY PRACTICE. EMR PROCEDURES WERE ACCOMPLISHED USING A SNARE OR THE MULTIBAND LIGATION DUETTE DEVICE (COOK MEDICAL) AFTER SUBMUCOSAL INJECTION OF SALINE SOLUTION COLORED BY INDIGO CARMINE. ESD WAS PERFORMED USING THE DUAL KNIFE (OLYMPUS) AFTER OUTLINE MARKING AND SUBMUCOSAL INJECTION OF SALINE SOLUTION COLORED BY INDIGO CARMINE.FIFTY-FIVE PATIENTS IN GROUP 1 (7F/48M, MEAN AGE (B)(6) YEARS) UNDERWENT WIDESPREAD ENDOSCOPIC RESECTION (ER) WITH ERADICATION OF RESIDUAL NON-DYSPLASTIC BE.THIRTY-FOUR PATIENTS IN GROUP 2 (3F/31M, MEAN AGE 67 YEARS) HAD A MULTIMODAL TREATMENT STRATEGY, WITH WIDESPREAD ER FOLLOWED BY RFA. COMPLETE ERADICATION OF HGD/IMC AND NON-DYSPLASTIC BE WAS CONFIRMED IN 26/27 (96.3%) AND 20/34 (58.8%) PATIENTS, RESPECTIVELY. THERE WAS NO SIGNIFICANT DIFFERENCE BETWEEN GROUPS CONCERNING ADVERSE EVENTS INCLUDES PERIOPERATIVE BLEEDING, STRICTURE DEVELOPMENT AND PERFORATION. MEAN FOLLOW UP TIME FOR ALL PATIENTS WAS 23.6 MONTHS. THIS STUDY CONCLUDES THAT A COMBINATION OF ER AND RFA CAN TREAT SIGNIFICANTLY LONGER NEOPLASTIC BE THAN ER ALONE, WITH THE SAME EFFICIENCY AND SAFETY. WIDESPREAD ER, IN CONTRAST, IS THE ONLY METHOD OF OBTAINING A RELIABLE HISTOLOGICAL DIAGNOSIS. THE CURRENTLY RECOMMENDED MANAGEMENT IS TO COMBINE ENDOSCOPIC MUCOSAL RESECTION (EMR) OR ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) OF ALL VISIBLE OR IRREGULAR LESIONS, COMPLEMENTED BY RADIOFREQUENCY ABLATION (RFA) OF ALL FLAT REMNANT BARRETT¿S TISSUE. ER, FOR BOTH VISIBLE LESIONS AND THE MAJORITY OF SURROUNDING BE TISSUE, WAS DONE BY EMR OR ESD. EMR PROCEDURES WERE ACCOMPLISHED USING A SNARE OR THE MULTIBAND LIGATION DUETTE® DEVICE (COOK MEDICAL) AFTER SUBMUCOSAL INJECTION OF SALINE SOLUTION COLORED BY INDIGO CARMINE. TO PERFORM ESD WE USED THE DUAL KNIFE® (OLYMPUS) AFTER OUTLINE MARKING AND SUBMUCOSAL INJECTION OF SALINE SOLUTION COLORED BY INDIGO CARMINE. BOTH EMR AND ESD WERE PREFERENTIALLY PERFORMED SEMI-CIRCUMFERENTIALLY, EXCEPT FOR CIRCUMFERENTIAL RESECTION IN SOME CASES OF SHORT BE. OLYMPUS DEVICE PROCEDURES: ER ALONE (GROUP 1) - 2 HAD ESD. ER FOLLOWED BY RFA - 3 HAD ESD. ADVERSE EVENTS: ER ALONE (GROUP 1) - 2 HAD ESD WITH OLYMPUS: STRICTURES (8). ER FOLLOWED BY RFA (GROUP 2) - 3 HAD ESD: STRICTURES (6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908105 SINGLE USE ELECTROSURGICAL KNIFE KD-650 SINGLE USE ELECTROSURGICAL KNIFE KNS OLYMPUS MEDICAL SYSTEMS CORP. KD-650L UNKNOWN(LITERATURE) 04953170265761

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other