BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 17476608 · Received August 7, 2023

    Report

    Report Number
    2955842-2023-17557
    Event Type
    Injury
    Date Received
    August 7, 2023
    Date of Event
    July 11, 2023
    Report Date
    July 11, 2023
    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
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH THERE IS NO CLAIM AGAINST THE PRODUCT AND NO INDICATION OF A PRODUCT ISSUE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THE ADVERSE EVENT. BASED ON THE INFORMATION GATHERED, THERE IS NO INDICATION THAT THE DEVICE DIRECTLY CAUSED THE ADVERSE EVENT. INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE A PRODUCT FOR EVALUATION. IF ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED. PER A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE, NO RELATED SYSTEM ERRORS OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED CHOLECYSTECTOMY PROCEDURE, THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL, DUE TO AN INTRA-OPERATIVE COMPLICATION. THE INITIAL CHOLECYSTECTOMY PROCEDURE WENT WELL AND WAS COMPLETED ROBOTICALLY. HOWEVER, AS THE SURGEON WAS CLOSING AT THE END OF THE PROCEDURE, HE NOTICED SOME BILE LEAKING. HE THOUGHT HE MAY HAVE CLIPPED THE CYSTIC DUCT, AND HE DISSECTED THE REMOVED GALLBLADDER. HE THEN DISCOVERED THAT THE COMMON BILE DUCT HAD BEEN TRANSECTED. PER THE SURGEON, THE INTRA-OPERATIVE COMPLICATION WAS RELATED TO THE PATIENT'S UNUSUAL ANATOMY, WHICH HE HAD NEVER SEEN BEFORE; IT WAS NOT CLEAR WHERE THE COMMON BILE DUCT WAS LOCATED, BUT IT WAS ASSUMED TO BE BELOW THE PLANE OF DISSECTION, AS USUAL. PRE-OPERATIVE SCANS SHOWED THAT THE COMMON BILE DUCT WAS SHORTER THAN IT WAS IN REALITY; HE DID NOT HAVE AN ANSWER AS TO WHY THIS WOULD BE. INTRA-OPERATIVE FIREFLY WAS USED, BUT THE COMMON BILE DUCT WAS NOT LOCATED. THE PATIENT WAS IMMEDIATELY TRANSFERRED TO ANOTHER FACILITY FOR TREATMENT, WHICH LIKELY INVOLVED PUTTING IN A DRAIN. NO MALFUNCTION OF THE DA VINCI SYSTEM OR ANY INSTRUMENTS OR ACCESSORIES OCCURRED. THE MEDICAL AND/OR SURGICAL INTERVENTIONS REQUIRED, THE PATIENT'S CURRENT STATUS, AND ANY CONCERNS REGARDING LONG-TERM COMPLICATIONS FOR THE PATIENT ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319257 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-51 N/A

    Patients

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