BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI X

    MDR report key: 14399223 · Received May 13, 2022

    Report

    Report Number
    2955842-2022-11596
    Event Type
    Injury
    Date Received
    May 13, 2022
    Date of Event
    June 5, 2020
    Report Date
    April 14, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115404
    PMA / PMN Number
    K171294
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE POST-OPERATIVE COMPLICATION CAN BE ATTRIBUTED TO THE PATIENT'S WEIGHT AND OBESITY PER THE SURGEON. 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. A REVIEW OF THE SYSTEM AND INSTRUMENT LOGS HAS BEEN PERFORMED. THERE WERE NO OBSERVED EVENTS IN THE AVAILABLE SYSTEM LOGS THAT WOULD SUGGEST A PRODUCT ISSUE, AND LOGGED EVENTS ARE IN LINE WITH NORMAL SYSTEM FUNCTIONALITY. ADDITIONALLY, ALL REUSABLE INSTRUMENTS USED IN THE CASE WERE USED IN SUBSEQUENT PROCEDURES AND A SITE REVIEW SHOWS NO COMPLAINT FILED AGAINST THE INSTRUMENTS. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. NO ADDITIONAL TECHNICAL REVIEW WAS REQUIRED BASED ON THE COMPLAINT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI-ASSISTED "ORGAN-PRESERVING RENAL TUMOR RESECTION LEFT" PROCEDURE, THE PATIENT HAD AN ABDOMINAL WALL DEFECT WITH HERNIATION OF MESENTERIC FAT AND SMALL INTESTINE. A TROCAR SITE HERNIA WAS DIAGNOSED ON POST-OPERATIVE DAY 84. THE HERNIA WAS TREATED WITH AN OPEN SURGICAL HERNIA CLOSURE WITH MESH INSERTION. THE SURGEON BELIEVES THAT THE CAUSE OF THE HERNIA WAS DUE TO THE PATIENT'S WEIGHT AND OBESITY. ALTHOUGH THERE IS NO ALLEGATION OF DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY MALFUNCTION DURING THE PROCEDURE, IT IS UNCLEAR AS TO WHAT EXTENT THE DA VINCI SURGICAL SYSTEM MAY HAVE CONTRIBUTED TO THE POST-OPERATIVE COMPLICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER UNDERGOING A DA VINCI-ASSISTED "ORGAN-PRESERVING RENAL TUMOR RESECTION LEFT" PROCEDURE, THE PATIENT HAD AN ABDOMINAL WALL DEFECT WITH HERNIATION OF MESENTERIC FAT AND SMALL INTESTINE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING INFORMATION: THERE WAS NO MALFUNCTION OF AN ISI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. THERE WAS NO VASCULAR INJURY INTRA-OPERATIVELY OR POST-OPERATIVELY. THERE WAS ALSO NO REPORT OF BLOOD LOSS DUE TO AN ISI PRODUCT. THE PATIENT HAD A TROCAR SITE HERNIA POST-OPERATIVELY WHICH WAS DIAGNOSED VIA MAGNETIC RESONANCE TOMOGRAPHY (MRT) ON DAY 84. THE PATIENT PRESENTED WITH PAIN AND DISCOMFORT. AN OPEN SURGICAL HERNIA CLOSURE WITH MESH INSERTION WAS USED TO TREAT THE HERNIA. THE SURGEON BELIEVES THAT THE CAUSE OF THE HERNIA WAS DUE TO THE PATIENT'S WEIGHT AND OBESITY. THE PATIENT IS CURRENTLY FEELING WELL. NO PHOTOGRAPHIC IMAGES OR A VIDEO RECORDING OF THE PROCEDURE ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1787864 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-33 N/A 00886874115404

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES