BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE ELECTROSURGICAL KNIFE KD-612

    MDR report key: 16855967 · Received May 2, 2023

    Report

    Report Number
    9614641-2023-00593
    Event Type
    Injury
    Date Received
    May 2, 2023
    Date of Event
    August 27, 2021
    Report Date
    May 25, 2023
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    KNS
    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 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 EVENTS 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, "EFFICACY OF SINGLE-BALLOON OVERTUBE FOR ENDOSCOPIC SUBMUCOSAL DISSECTION IN THE PROXIMAL COLON: A PROPENSITY SCORE-MATCHED ANALYSIS". OBJECTIVES: A SINGLE-BALLOON OVERTUBE (SBO) CAN IMPROVE POOR SCOPE OPERABILITY DURING COLONIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD).WE AIMED TO EVALUATE THE CLINICAL USEFULNESS OF SBO FOR ESD IN THE PROXIMAL COLON AND THE PREDICTIVE FACTORS FOR CASES IN WHICH SBO IS USEFUL. METHODS: A TOTAL OF 88 TUMORS LOCATED IN THE PROXIMAL COLON RESECTED BY BALLOON-ASSISTED ESD (BA-ESD) USING SBO AND 461 TUMORS RESECTED BY CONVENTIONAL ESD (C-ESD) BETWEEN JUNE 2015 AND NOVEMBER 2020 WERE CONSIDERED. SEVENTY-EIGHT TUMORS EACH IN THE BA-ESD AND C-ESD GROUPS WERE MATCHED BY PROPENSITY SCORE MATCHING. ESD OUTCOMES WERE COMPARED BETWEEN THE GROUPS, AND A DECISION TREE ANALYSIS WAS PERFORMED TO EXPLORE THE PREDICTIVE FACTORS FOR CASES IN WHICH SBO IS USEFUL. RESULTS: THERE WERE NO SIGNIFICANT DIFFERENCES BETWEEN THE GROUPS IN THE MAJOR OUTCOMES SUCH AS EN BLOC RESECTION RATE (95% VS. 99%, P = 0.17), R0 RESECTION RATE (92% VS. 96%, P = 0.30), MEAN DISSECTION SPEED (16 MM2/MIN VS. 16 MM2/MIN,P = 0.53), AND INTRAOPERATIVE PERFORATION RATE (5% VS. 6%,P = 0.73). EVEN WHEN CONSIDERING CASES WITH POOR PREOPERATIVE SCOPE OPERABILITY, THERE WERE NO SIGNIFICANT DIFFERENCES BETWEEN THE GROUPS. COMPARISON OF TUMORS =40 MM IN DIAMETER BETWEEN THE GROUPS CONFIRMED THAT THE INTRAOPERATIVE PERFORATION RATE WAS SIGNIFICANTLY LOWER IN THE BA-ESD GROUP THAN IN THE C-ESD GROUP (0% VS. 24%, P = 0.0188). CONCLUSION: SBO IS USEFUL FOR ESD OF TUMORS =40 MM IN DIAMETER IN THE PROXIMAL COLON TO PREVENT INTRAOPERATIVE PERFORATION, WHICH USUALLY HAS A LONG PROCEDURE TIME. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: INTRAOPERATIVE PERFORATION (BA-ESD) (4 PATIENTS). INTRAOPERATIVE PERFORATION (C-ESD) (5 PATIENTS). DELAYED PERFORATION (BA-ESD) (1 PATIENTS). POSTOPERATIVE BLEEDING (BA-ESD) (3 PATIENTS). POSTOPERATIVE BLEEDING (C-ESD) (1 PATIENTS). PREOPERATIVE SCOPE OPERABILITY (POOR) (27+249 = 266). INTRAOPERATIVE SCOPE OPERABILITY (POOR) (3+130 = 133). THIS LITERATURE ARTICLE REQUIRES 9 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE BELOW. THE FOLLOWING REPORTS ARE FOR THE ADVERSE EVENTS: (B)(6) COLONOSCOPE (PCF-Q260AZI). (B)(6) COLONOSCOPE (PCF-H290TI). (B)(6) STANDARD TIP HOOD (MH-463 AS DISTAL ATTACHMENT). (B)(6) DUALKNIFE (KD-655L AS SINGLE USE ELECTROSURGICAL KNIFE KD-650). (B)(6) DUALKNIFE J (KD-655Q AS SINGLE USE ELECTROSURGICAL KNIFE KD-655). (B)(6) TKNIFE NANO (KD-612Q AS SINGLE USE ELECTROSURGICAL KNIFE KD-612). (B)(6) SBO (ST-CB1). IN ADDITION, THE FOLLOWING REPORTS ARE FOR THE "SCOPE OPERABILITY (FAIR)" SCOPE MALFUNCTION. (B)(6) PCF-Q260AZI (IUC GIB BENDING MANIPULATION AND INSERTION TUBE DEFECTS). (B)(6) PCF-H290TI (IUC GIB BENDING MANIPULATION AND INSERTION TUBE DEFECTS) THIS MEDWATCH REPORT IS FOR PATIENT IDENTIFIER (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1800336 SINGLE USE ELECTROSURGICAL KNIFE KD-612 SINGLE USE ELECTROSURGICAL KNIFE KNS AOMORI OLYMPUS CO., LTD. KD-612Q UNKNOWN(LITERATURE)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other