BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONICBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP

    MDR report key: 16791910 · Received April 21, 2023

    Report

    Report Number
    9614641-2023-00549
    Event Type
    Injury
    Date Received
    April 21, 2023
    Date of Event
    February 1, 2023
    Report Date
    May 25, 2023
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    LFL
    UDI-DI
    04953170370540
    PMA / PMN Number
    K211838
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND CORRECTION TO THE INITIAL WITH INFORMATION INADVERTENTLY LEFT OUT (D8, H8). 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.

    Additional Manufacturer Narrative · 0

    H6: HEALTH EFFECT CLINICAL CODE TERM: PERITONEAL INJURY. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "PREOPERATIVE SUBCUTANEOUS FAT IS AN USEFUL INDICATOR FOR LEARNING TOTALLY EXTRAPERITONEAL REPAIR". LITERATURE SUMMARY BACKGROUND: TOTALLY EXTRAPERITONEAL (TEP) REPAIR IS A RECOMMENDED PROCEDURE FOR INGUINAL HERNIA REPAIR IN EUROPEAN HERNIA GUIDELINES. HOWEVER, TECHNICAL CHALLENGES HAVE LIMITED ITS UPTAKE IN JAPAN, WHERE TRANSABDOMINAL PREPERITONEAL (TAPP) REPAIR IS MORE COMMON. WE EVALUATED THE ASSOCIATION OF PREOPERATIVE SUBCUTANEOUS FAT AREA (PRESFA) WITH SURGICAL OUTCOMES AND IDENTIFIED FACTORS ASSOCIATED WITH THE DIFFICULTY OF TEP REPAIR. METHODS: CLINICAL DATA FROM 62 PATIENTS UNDERGOING TEP REPAIR WERE COLLECTED RETROSPECTIVELY. USING THE MEDIAN FOR THE PREOPERATIVE SUBCUTANEOUS FAT INDEX (PRESFI; 45.9 CM'/M2), WE CLASSIFIED PATIENTS AS HAVING A HIGH SFI (HSFI) (N=31) AND LOW SFI (LSFI) (N=31). SURGICAL OUTCOMES AND PERIOPERATIVE COMPLICATIONS WERE THEN COMPARED BETWEEN THESE GROUPS. ADDITIONALLY, TEP REPAIR WAS DIVIDED INTO FIVE PHASES (E.G., PHASE 1: DISSECTION OF THE CAUDAL SIDE OF THE PREPERITONEAL SPACE), AND OPERATIVE TIME WAS MEASURED DURING EACH PHASE. PHASE 1 WAS DIVIDED INTO TWO SUB-PHASES (1A: INSERTION OF THE FIRST PORT, 1B: REACHING COOPER'S LIGAMENT). RESULTS: OPERATIVE TIME WAS LONGER (133 MIN VS 111 MIN, P = 0.028) AND THE PERITONEAL INJURY RATE WAS HIGHER (35.5% VS 9.7%, P = 0.015) FOR THE HSFI PATIENTS. FURTHERMORE, OPERATIVE TIME FOR HSFI PATIENTS WAS SIGNIFICANTLY LONGER DURING PHASE 1 (P = 0.014) AND PHASE 1A (P = 0.022). CONCLUSIONS: PRESFA WAS ASSOCIATED WITH A HIGHER PERITONEAL INJURY RATE AND LONGER OPERATIVE TIME IN HSFI PATIENTS, SUGGESTING THAT THE PRESENCE OF ABUNDANT SUBCUTANEOUS FAT INCREASES THE DIFFICULTY OF TEP REPAIR. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: PERITONEAL INJURY (14 PATIENTS) , CONVERSION TO TAPP (3 PATIENTS), SEROMA (7 PATIENTS) , SURGICAL SITE INFECTION (3 PATIENTS). ATTEMPTS TO OBTAINED ADDITIONAL INFORMATION WERE MADE BUT UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964940 SONICBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP INSTRUMENT LFL AOMORI OLYMPUS CO., LTD. SB-0535FC UNKNOWN(LITERATURE) 04953170370540

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other