BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 13387363 · Received January 28, 2022

    Report

    Report Number
    2955842-2022-10136
    Event Type
    Injury
    Date Received
    January 28, 2022
    Date of Event
    November 5, 2021
    Report Date
    January 14, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    UNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSES OF THE POST-OPERATIVE COMPLICATIONS ARE UNKNOWN. ISI HAS ATTEMPTED TO CONTACT THE ARTICLE CORRESPONDENCE OR SITE TO GATHER ADDITIONAL INFORMATION REGARDING THE PATIENT/INCIDENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO NEW INFORMATION HAS BEEN OBTAINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. AS OF 18-JAN-2022, A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. A REVIEW OF THE SYSTEM AND INSTRUMENT LOGS IS NOT POSSIBLE DUE TO LACK OF SYSTEM AND INSTRUMENT DETAILS, EVENT/PROCEDURE DATES, AND CONFIRMATION OF SITE LOCATION(S). THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: WITHIN THE SURGICAL ENDOSCOPY ARTICLE TITLED, ¿CHANGES IN OUTCOMES AND OPERATIVE TRENDS WITH PEDIATRIC ROBOT-ASSISTED RESECTION OF CHOLEDOCHAL CYST," POST-OPERATIVE COMPLICATIONS INVOLVING DA VINCI-ASSISTED SURGICAL PROCEDURES WERE NOTED. A NUMBER OF THE PATIENTS WHO EXPERIENCED THE POST-OPERATIVE COMPLICATIONS REQUIRED MEDICAL INTERVENTION. THE CAUSES OF THE POST-OPERATIVE COMPLICATIONS ARE UNKNOWN.

    Description of Event or Problem · 0

    INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A SURGICAL ENDOSCOPY ARTICLE TITLED, ¿CHANGES IN OUTCOMES AND OPERATIVE TRENDS WITH PEDIATRIC ROBOT-ASSISTED RESECTION OF CHOLEDOCHAL CYST¿ (IHN, K., HO, I. G., ET AL., 2021). WITHIN THE JOURNAL ARTICLE, OPERATIVE COMPLICATIONS INVOLVING A DA VINCI-ASSISTED SURGICAL PROCEDURE WERE NOTED. PER THE JOURNAL ARTICLE, THE FOLLOWING WAS NOTED: "FIVE PATIENTS HAD POSTOPERATIVE BILIARY COMPLICATIONS, WITH FOUR PATIENTS IN THE P1 GROUP. OF THESE, 2 PATIENTS REQUIRED A PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE (PTBD), AND 3 RECOVERED FROM MINOR BILE LEAKAGE CONSERVATIVELY. POSTOPERATIVE WOUND COMPLICATIONS OCCURRED IN FIVE CASES. ALL FIVE PATIENTS WITH INTESTINAL OBSTRUCTIONS REQUIRED REOPERATION. THERE WAS ONLY ONE CASE OF INTESTINAL PERFORATION, WHICH WAS REPAIRED BY A LAPAROSCOPIC APPROACH. OTHER COMPLICATIONS INCLUDED IATROGENIC HYDROTHORAX AFTER CENTRAL VENOUS CATHETER DISLOCATION DURING ANESTHESIA (N = 1), INTRAABDOMINAL FLUID COLLECTION (N = 2), PANCREATITIS (N = 1), AND A TWISTED ROUX LIMB (N = 2). REVISIONAL SURGERY WAS PERFORMED IN ONE PATIENT WITH A TWISTED ROUX LIMB; THE REMAINING PATIENT GAINED FULL ORAL INTAKE WITHOUT ADDITIONAL SURGERY." ISI HAS ATTEMPTED TO FOLLOW-UP WITH THE ARTICLE CORRESPONDENCE TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1684175 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