BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI SI

    MDR report key: 16078301 · Received December 30, 2022

    Report

    Report Number
    2955842-2022-16219
    Event Type
    Injury
    Date Received
    December 30, 2022
    Report Date
    December 2, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSES OF THE OPERATIVE COMPLICATIONS LEADING TO CONVERSIONS CANNOT BE DETERMINED. THERE IS NO ALLEGATION OR REPORT OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A SYSTEM LOG REVIEW CANNOT BE PERFORMED DUE TO INSUFFICIENT INFORMATION PROVIDED. THE EVENT DATES AND DA VINCI SYSTEM INFORMATION ARE UNKNOWN. NO IMAGE OR VIDEO CLIPS FOR THE REPORTED EVENT WERE SUBMITTED BY THE CUSTOMER FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING DA VINCI-ASSISTED COMPONENT SEPARATION TAR PROCEDURES, EIGHT PATIENTS EXPERIENCED CONVERSIONS TO OPEN SURGERY. THE ISSUE OCCURRED DUE TO ADHESIONS, SEVERE BLEEDING, SMALL BOWEL INJURY, AND FULL-THICKNESS STOMACH INJURY. HOWEVER, THE CAUSES OF THE OPERATIVE COMPLICATIONS LEADING TO CONVERSIONS ARE UNKNOWN.

    Description of Event or Problem · 0

    ON 02-DEC-2022, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A BRITISH JOURNAL OF SURGERY (BJS) OPEN ARTICLE TITLED, ¿OPEN VERSUS ROBOTIC-ASSISTED LAPAROSCOPIC POSTERIOR COMPONENT SEPARATION IN COMPLEX ABDOMINAL WALL REPAIR¿ (DEWULF, M., HIEKKARANTA, J.M., ET AL., 2022). STUDY DATA WAS COLLECTED BETWEEN DECEMBER 2011 AND OCTOBER 2019 AT MARIA MIDDELARES HOSPITAL, GHENT, BELGIUM (MMH); AND BETWEEN AUGUST 2017 AND MAY 2021 AT OULU UNIVERSITY HOSPITAL, OULU, FINLAND (OUH), WITH A TOTAL OF 169 PATIENTS (RTAR: N=90, OTAR: N=79). THE ARTICLE DESCRIBES A TWO-CENTRE CASE-CONTROL STUDY USING A PROSPECTIVELY DEVELOPED DATABASE (EUROPEAN REGISTRY FOR ABDOMINAL WALL HERNIAS (EURAHS)13) BASED ON ELECTRONIC CLINICAL FILES FROM PATIENTS UNDERGOING BILATERAL PCST (EITHER OPEN OR ROBOTIC-ASSISTED). THE PURPOSE OF THE STUDY WAS TO COMPARE OUTCOMES OF OPEN (OTAR) VERSUS ROBOTIC ASSISTED (RTAR) POSTERIOR COMPONENT SEPARATION BY TRANSVERSUS ABDOMINIS RELEASE (TAR). PATIENTS WERE OPERATED BY A SINGLE SURGEON IN MMH AND BY TWO SURGEONS AT OUH. THE ROBOTIC-ASSISTED SURGICAL PROCEDURES WERE PERFORMED WITH THE DA VINCI XI OR SI SYSTEMS. WITHIN THE JOURNAL ARTICLE, SEVERAL CONVERSIONS INVOLVING DA VINCI VENTRAL HERNIA PROCEDURES WERE NOTED. PER THE ARTICLE, THERE WERE EIGHT CONVERSIONS TO OPEN SURGERY IN THE RTAR GROUP DUE TO ADHESIONS (N=8), SEVERE BLEEDING (N=2), SMALL BOWEL INJURY (N=1), AND FULL-THICKNESS STOMACH INJURY (N=1). ALL PATIENTS HAD A FOLLOW-UP VISIT DURING THE FIRST 3 MONTHS AFTER SURGERY. AT MMH, A ROUTINE CLINICAL FOLLOW-UP VISIT 1 YEAR AFTER SURGERY WAS PERFORMED. DURING THESE FOLLOW-UP PERIODS, FIVE PATIENTS EXPERIENCED HERNIA RECURRENCE AND FOUR PATIENTS REQUIRED REOPERATION. TWO DEATHS OCCURRED IN THE RTAR GROUP WITHIN 30 DAYS AFTER SURGERY. IN-HOSPITAL COMPLICATIONS, OVERALL COMPLICATION RATES, AND SURGICAL SITE INFECTIONS (SSIS) DURING THE FIRST 30 POSTOPERATIVE DAYS WERE SIGNIFICANTLY LOWER IN THE RTAR GROUP, WHEREAS SURGICAL SITE OCCURRENCES (SSOS), SURGICAL SITE OCCURRENCES REQUIRING PERCUTANEOUS INTERVENTION (SSOPIS), AND READMISSION RATES WERE SIMILAR. MAJOR POSTOPERATIVE COMPLICATIONS (CLAVIEN-DINDO GRADE III AND ABOVE) WERE SIGNIFICANTLY HIGHER IN THE OTAR GROUP (7.8 PER CENT VERSUS 20.3 PERCENT; 0.018). AFTER ADJUSTING FOR SMOKING AND HERNIA WIDTH, THE OTAR GROUP HAD AN OR OF 2.4 (95 PER CENT CONFIDENCE INTERVAL 0.88 TO 6.4; 0.087) FOR MAJOR POSTOPERATIVE COMPLICATIONS. TWO DEATHS OCCURRED IN EACH GROUP WITHIN 30 DAYS OF SURGERY. FOLLOW-UP WAS SIGNIFICANTLY LONGER IN THE OTAR GROUP (43 VERSUS 19 MONTHS; P,0.001) AND REVEALED A REOPERATION RATE OF 4.4 PER CENT IN THE RTAR GROUP AND 8.9 PER CENT IN THE OTAR GROUP (P,0.246). HERNIA RECURRENCE WAS SIMILAR BETWEEN GROUPS (5.6 PER CENT VERSUS 5.2 PER CENT). CONCLUSION: PATIENTS WITH VENTRAL HERNIAS WHO UNDERGO BILATERAL RTAR HAD SIGNIFICANTLY SHORTER POSTOPERATIVE HOSPITAL STAYS, AND FEWER SHORT-TERM COMPLICATIONS COMPARED WITH PATIENTS UNDERGOING BILATERAL OTAR. ATTEMPTS TO CONTACT THE AUTHORS FOR ADDITIONAL SPECIFIC INFORMATION REGARDING EVENTS PER SITE, THE DA VINCI SYSTEM USED PER EVENT, AND THE SPECIFIC PATIENT INFORMATION WERE UNSUCCESSFUL. THIS REPORT PERTAINS TO THE SERIOUS INJURIES NOTED IN TABLE 2 (EIGHT CONVERSIONS DUE TO ADHESIONS, SEVERE BLEEDING, SMALL BOWEL INJURY, AND FULL-THICKNESS STOMACH INJURY) WITHIN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2409853 DAVINCI SI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380614-06 N/A

    Patients

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