BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE

    MDR report key: 13996393 · Received April 4, 2022

    Report

    Report Number
    8010047-2022-05619
    Event Type
    Injury
    Date Received
    April 4, 2022
    Date of Event
    December 16, 2020
    Report Date
    May 20, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GCJ
    UDI-DI
    04953170310355
    PMA / PMN Number
    K201832
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 CAN BE FOUND AT: DOI: 10.5152/TUD.2020.20439. 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 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

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE ARTICLE "IMPACT OF THREE-DIMENSIONAL VISION IN LAPAROSCOPIC PARTIAL NEPHRECTOMY FOR RENAL TUMORS" BY THEODOROS TOKAS, ET AL. TO COMPARE THREE-DIMENSIONAL (3D) WITH STANDARD TWO-DIMENSIONAL (2D) LAPAROSCOPIC PARTIAL NEPHRECTOMY (LPN) WITH RESPECT TO INTRA- AND POSTOPERATIVE OUTCOMES. MATERIAL AND METHODS: DATA FROM 112 PATIENTS WHO UNDERWENT TRANSPERITONEAL LPN FROM 2012 TO 2014 BY A SINGLE EXPERIENCED SURGEON WERE COLLECTED. SIXTY PATIENTS (GROUP 1) UNDERWENT CONVENTIONAL 2D LPN AND 52 PATIENTS (GROUP 2) 3D LPN. PERIOPERATIVE PATIENT, PROCEDURE, AND TUMOR DATA WERE RECORDED. THE FOLLOW-UP PERIOD WAS 1¿5 YEARS. RESULTS: THE TWO GROUPS HAD SIMILAR PATIENT AGE (P=0.834) AND BODY MASS INDEX (P=0.141). THE TOTAL LAPAROSCOPY TIME (LT) WAS SHORTER IN GROUP 2 (119.0 VS. 106.0 MIN; P=0.009). WARM ISCHEMIA TIMES (WITS) WERE ALSO SHORTER IN GROUP 2 (11.5 VS. 10.0 MIN; P=0.032). THE ESTIMATED BLOOD LOSS (EBL) (350.0 VS. 250.0 ML; P<0.001) AND HEMOGLOBIN (HB) DECREASE (1.55 VS. 1.35 G/DL; P=0.536) WERE LOWER IN THE 3D LPN GROUP. CREATININE (0 VS. 0 G/DL; P=0.610) INCREASE AND ESTIMATED GLOMERULAR FILTRATION RATE (EGFR) DECREASE (0 VS. 0 ML/MIN/1.73 M2; P=0.553) DID NOT DEMONSTRATE STATISTICALLY SIGNIFICANT DIFFERENCES. DURATION OF HOSPITALIZATION (7 VS. 7 DAYS; P=0.099) AND COMPLICATION RATES (P=0.559) WERE SIMILAR BETWEEN THE TWO GROUPS. CONCLUSION: THE NEW-GENERATION 3D LAPAROSCOPE HAS A GREAT IMPACT ON SIGNIFICANT LPN INTRAOPERATIVE PARAMETERS, MAINLY LT, WIT, AND EBL. HB DECREASE IS ALSO IN FAVOR OF 3D VISION, ALTHOUGH NOT DRAMATICALLY ALTERED. THEREFORE, 3D LPN APPEARS TO BE SUPERIOR TO CONVENTIONAL 2D LPNS. THE AUTHORS REPORTED THE FOLLOWING ADVERSE EVENTS BUT DID NOT PROVIDE ANY ADDITIONAL DETAILS. CLAVIEN 1 - 3 (3D) ANY DEVIATION FROM THE NORMAL POSTOPERATIVE COURSE WITHOUT THE NEED FOR PHARMACOLOGICAL TREATMENT OR SURGICAL, ENDOSCOPIC AND RADIOLOGICAL INTERVENTIONS ALLOWED THERAPEUTIC REGIMENS ARE: DRUGS AS ANTIEMETICS, ANTIPYRETICS, ANALGESICS, DIURETICS AND ELECTROLYTES AND PHYSIOTHERAPY. THIS GRADE ALSO INCLUDES WOUND INFECTIONS OPENED AT THE BEDSIDE. CLAVIEN 2 - (3D) REQUIRING PHARMACOLOGICAL TREATMENT WITH DRUGS OTHER THAN SUCH ALLOWED FOR GRADE I COMPLICATIONS. BLOOD TRANSFUSIONS AND TOTAL PARENTERAL NUTRITION ARE ALSO INCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498692 ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE FLEX DEFLECTABLE VIDEOSCOPE GCJ OLYMPUS MEDICAL SYSTEMS CORP. LTF-S190-5 04953170310355

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other