BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 14595135 · Received June 3, 2022

    Report

    Report Number
    2955842-2022-11996
    Event Type
    Injury
    Date Received
    June 3, 2022
    Report Date
    May 4, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSES OF THE PATIENTS' REPORTED POSTOPERATIVE COMPLICATIONS CANNOT BE DETERMINED OR ARE UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. THERE WAS NO IMAGE OR VIDEO CLIP SUPPLIED FOR REVIEW RELATED TO A SPECIFIC EVENT. SYSTEM OR INSTRUMENT LOG REVIEWS COULD NOT BE PERFORMED DUE TO A LACK OF SYSTEM, PROCEDURE, AND INSTRUMENT DETAILS. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING: IN THE JOURNAL ARTICLE TITLED, ¿ROBOTIC TRANSABDOMINAL RETROMUSCULAR RECTUS DIASTASIS (R-TARRD) REPAIR: A NEW APPROACH,¿ IT IS NOTED THAT A NUMBER OF POST-OPERATIVE COMPLICATIONS OCCURRED. AT THIS TIME THE CAUSES OF THE POST-OPERATIVE COMPLICATIONS ARE UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE MISSING PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EVEN DATE IS UNKNOWN. THE EXPIRATION DATE IS NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE. INSUFFICIENT PRODUCT INFORMATION WAS PROVIDED IN ORDER TO OBTAIN THE DATE OF MANUFACTURE.

    Description of Event or Problem · 0

    INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A HERNIA JOURNAL ARTICLE TITLED, ¿ROBOTIC TRANSABDOMINAL RETROMUSCULAR RECTUS DIASTASIS (R-TARRD) REPAIR: A NEW APPROACH¿ (CUCCURULLO, D., GUERRIERO, L., ET AL., 2022). WITHIN THE JOURNAL ARTICLE, POST-OPERATIVE COMPLICATIONS INVOLVING A DA VINCI-ASSISTED SURGICAL PROCEDURE WERE NOTED. THE PURPOSE OF THE STUDY IS TO PRESENT AN INNOVATIVE ROBOTIC APPROACH FOR THE TREATMENT OF RECTUS DIASTASIS WITH CONCURRENT PRIMARY OR INCISIONAL VENTRAL HERNIAS. FORTY-FIVE R-TARRD REPAIRS FOR SYMPTOMATIC RECTUS DIASTASIS WITH CONCOMITANT ASSOCIATED VENTRAL/INCISIONAL UMBILICAL AND/OR EPIGASTRIC HERNIAS WERE PERFORMED BETWEEN JANUARY 2019 AND JANUARY 2020. THE PROCEDURE WERE PERFORMED BY A SINGLE SURGEON USING THE DA VINCI XI ROBOTIC PLATFORM. PER THE JOURNAL ARTICLE, AT ONE MONTH FOLLOW-UP, ONE PATIENT EXPERIENCED A MESH INFECTION WHICH WAS TREATED CONSERVATIVELY AFTER CLINICAL AND ULTRASOUND EXAMINATION. FOUR RECURRENCES WERE REPORTED AT ONE-YEAR FOLLOW-UP. TWO OF RECURRENCES WERE SYMPTOMATIC AND WERE TREATED WITH RE-INTERVENTION: ONE INTRAPERITONEAL ONLAY MESH REPAIR (IPOM) AND ONE OPEN REPAIR. THE IPOM TECHNIQUE WAS USED FOR A PATIENT WITH A 3 CM EPIGASTRIC INCISIONAL HERNIA RECURRENCE AND THE OPEN APPROACH WAS USED IN A PATIENT WITH A TOTAL RUPTURE OF THE CLOSURE OF THE LARGE EPIGASTRIC DEFECT AND THE LINEA ALBA PLICATION. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1834248 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DA VINCI INSTRUMENTS AND ACCESSORIES.