BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S

    MDR report key: 14025510 · Received April 6, 2022

    Report

    Report Number
    8010047-2022-05812
    Event Type
    Injury
    Date Received
    April 6, 2022
    Date of Event
    January 1, 2022
    Report Date
    April 6, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GEI
    UDI-DI
    04953170383540
    PMA / PMN Number
    K211838
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED REPORT ADVERSE EVENTS AND TO PROVIDE INVESTIGATION RESULTS NO PHYSICAL EVALUATION/INSPECTION COULD BE CONDUCTED ON THE SUSPECT DEVICE AS IT WAS NOT RETURNED TO OLYMPUS. THE DEVICE HISTORY RECORD (DHR) FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED SINCE THE SERIAL NUMBER WAS NOT PROVIDED. OLYMPUS DOES NOT SHIP ANY DEVICE THAT DOES NOT MEET ALL DESIGN AND SAFETY SPECIFICATIONS. THERE WAS NO REPORT OF OLYMPUS DEVICE MALFUNCTION AND NO INFORMATION CONNECTING THE CAUSE OF THE REPORTED EVENTS TO THE DEVICE. FOR THESE REASONS, THE DEFINITIVE CAUSE OF THE REPORTED EVENTS COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT IS REPORTED IN THE LITERATURE TITLED ¿ROBOTIC SINGLE-PORT MYOMECTOMY USING THE DA VINCI SP SURGICAL SYSTEM: A PILOT STUDY,¿ PATIENTS EXPERIENCED ADVERSE EVENTS DURING OR AFTER ROBOTIC SINGLE-PORT MYOMECTOMY PROCEDURES USING A THUNDERBEAT. TO REPORT OUR INITIAL EXPERIENCE WITH ROBOTIC SINGLE-PORT MYOMECTOMY (RSPM) USING THE DA VINCI SP SURGICAL SYSTEM AND TO EVALUATE THE FEASIBILITY OF THE PROCEDURE. PROSPECTIVE OBSERVATIONAL STUDY WAS PERFORMED AT A UNIVERSITY TEACHING HOSPITAL FROM JANUARY 2019 TO DECEMBER 2019. SIXTY-ONE WOMEN WITH SYMPTOMATIC FIBROIDS RECEIVED RSPM. BASED ON SEVEN RESECTED FIBROIDS AND A MAXIMAL DIAMETER OF RESECTED FIBROIDS <10 CM, THE WOMEN WERE ARBITRARILY DIVIDED INTO TWO GROUPS. THE MEAN NUMBER AND MAXIMAL DIAMETER OF THE REMOVED FIBROIDS WERE 3.7 ± 3.8 (2.3 ± 1.8 IN GROUP 1 VS. 7.2 ± 5.3 IN GROUP 2) AND 7.6 ± 2.9 CM (6.8 ± 1.6 IN GROUP 1 VS. 9.5 ± 4.3 IN GROUP 2), RESPECTIVELY. THE MEAN OPERATION TIME, HEMOGLOBIN CHANGE, AND HOSPITAL STAY WERE 149.9 ± 72.9 MIN (123.8 ± 43.8 IN GROUP 1 VS. 217.6 ± 89.4 IN GROUP 2), 2.3 ± 1.0 G/DL (2.1 ± 0.9 IN GROUP 1 VS. 2.7 ± 1.2 IN GROUP 2), AND 4.5 + 0.8 DAYS (4.4 + 0.8 IN GROUP 1 VS. 4.7 ± 0.9 IN GROUP 2). THERE WAS NO CONVERSION TO MULTI-PORT LAPAROSCOPY OR LAPAROTOMY NOR WERE THERE ANY MAJOR COMPLICATIONS. CONCLUSIONS: RSPM USING THE DA VINCI SP SURGICAL SYSTEM IS FEASIBLE SURGICAL MODALITY FOR WOMEN WITH SYMPTOMATIC FIBROID AND IS EXPECTED TO INCREASE INDICATIONS OF SINGLE-PORT MYOMECTOMY BY SOLVING MANY OF THE ERGONOMICS PROBLEMS INEVITABLY ACCOMPANYING SINGLE-PORT LAPAROSCOPIC MYOMECTOMY. KEY WORDS: GYNECOLOGY, LAPAROSCOPY, MYOMECTOMY, ROBOTIC SURGERY, SINGLE-PORT SURGERY. THERE WAS NO CONVERSION TO SINGLE-PORT LAPAROSCOPIC MYOMECTOMY, MULTIPORT LAPAROSCOPIC MYOMECTOMY, OR LAPAROTOMIC MYOMECTOMY. OPERATIVE COMPLICATIONS WERE FOUND AND RESOLVED BY CONSERVATIVE TREATMENTS IN 15 WOMEN. THE HISTOPATHOLOGICAL RESULT FOR ALL RESECTED FIBROIDS WAS LEIOMYOMA. THERE IS NO REPORT OF OLYMPUS DEVICE MALFUNCTION DESCRIBED IN THIS STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1441823 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0535FCS UNKNOWN(LITERATURE) 04953170383540

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other| R