BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI

    MDR report key: 13285750 · Received January 18, 2022

    Report

    Report Number
    2955842-2022-10093
    Event Type
    Injury
    Date Received
    January 18, 2022
    Date of Event
    November 30, 2020
    Report Date
    December 23, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K112263
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) WILL NOT RECEIVE THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FOR EVALUATION BECAUSE IT WAS DISCARDED FOLLOWING REMOVAL FROM THE PATIENT'S ANATOMY. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED, YET SEEMS POTENTIALLY RELATED TO USE ERROR (A RETAINED FOREIGN BODY THAT WAS MISSED DURING THE ITEM COUNT). A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THE MCS TIP COVER ACCESSORY INFORMATION CANNOT BE VERIFIED THROUGH THE SYSTEM LOG REVIEW AS THERE ARE NO LOGS AVAILABLE FOR ACCESSORIES. IN ADDITION, A REVIEW OF THE SITE'S COMPLAINT HISTORY IDENTIFIED NO OTHER COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED TO ISI FOR REVIEW. THIS COMPLAINT IS DEEMED A REPORTABLE EVENT BASED ON THE FOLLOWING: A FOREIGN OBJECT WAS IDENTIFIED IN THE PATIENT'S ABDOMEN DURING A COMPUTED TOMOGRAPHY (CT) SCAN. THE OBJECT WAS SUSPECTED TO BE AN MCS TIP COVER ACCESSORY FROM A SURGERY PERFORMED ABOUT A YEAR EARLIER. THE PATIENT UNDERWENT A PROCEDURE AND THE FOREIGN OBJECT WAS RETRIEVED. THE RETRIEVED OBJECT WAS DISCARDED AND NO PHOTOS OF THE OBJECT WERE SHARED. IT IS UNKNOWN IF THE FOREIGN OBJECT WAS AN MCS TIP COVER ACCESSORY, AND IF SO, WHY IT FELL INSIDE THE PATIENT AND WAS RETAINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A COMPUTED TOMOGRAPHY (CT) SCAN THAT WAS PERFORMED FOR AN UNKNOWN REASON, A FOREIGN BODY WAS FOUND TO BE INSIDE THE PATIENT¿S ABDOMEN. THE ITEM WAS SUSPECTED TO BE A MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FROM A PROSTATECTOMY SURGERY PERFORMED IN (B)(6) 2020. AN UNKNOWN TYPE OF PROCEDURE WAS PERFORMED ON (B)(6) 2021 TO REMOVE THE FOREIGN BODY. INTUITIVE SURGICAL, INC. (ISI) PERFORMED FOLLOW-UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE PROCEDURE IN (B)(6) 2020. THE CUSTOMER STATED THAT THE MCS TIP COVER ACCESSORY WAS INSTALLED ON THE MCS INSTRUMENT DURING THE ENTIRE PROCEDURE, AND THE INSTRUMENT PERFORMED AS INTENDED. THE SURGICAL STAFF DID NOT USE A REDUCER OR INSTALLATION TOOL DURING THIS REPORTED PROCEDURE. THE SURGICAL STAFF ALSO DID NOT APPLY ELECTROLUBE OR ANY OTHER LUBRICANT TO THE MCS INSTRUMENT PRIOR TO INSTALLING THE MCS TIP COVER ACCESSORY. THE SURGICAL STAFF DID NOT SEE ANY DAMAGE ON THE MCS TIP COVER ACCESSORY, MCS INSTRUMENT, OR CANNULA AFTER THE PROCEDURE. ALTHOUGH REQUESTED, THE FOLLOWING INFORMATION WAS UNKNOWN: IF THE MCS INSTRUMENT AND MCS TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE, WHETHER THERE WAS ANY RESISTANCE WHILE REMOVING THE MCS INSTRUMENT THROUGH THE CANNULA, IF THE MCS TIP COVER ACCESSORY WAS PROPERLY INSTALLED ON THE MCS INSTRUMENT, OR IF THERE WERE ANY INSTRUMENT COLLISIONS. THE FOREIGN BODY THAT WAS RETRIEVED AND ALLEGED TO BE AN MCS TIP COVER ACCESSORY WILL NOT BE RETURNED TO ISI FOR EVALUATION AS IT WAS DISCARDED BY THE SITE. NO IMAGES OF THE ITEM THAT WAS RETRIEVED WERE AVAILABLE FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821056 DAVINCI TIP COVER ACCESSORY NAY INTUITIVE SURGICAL, INC 400180 UNKNOWN

    Patients

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