BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 16170516 · Received January 15, 2023

    Report

    Report Number
    2955842-2023-10103
    Event Type
    Injury
    Date Received
    January 15, 2023
    Date of Event
    December 16, 2022
    Report Date
    December 16, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE SINGLE PORT (SP) MONOPOLAR CURVED SCISSORS (MCS) TIP ACCESSORY FELL INTO PATIENT, AN INVESTIGATION IS IN PROGRESS. INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE SP MCS TIP ACCESSORY FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. THE INVESTIGATION TO DETERMINE THE CAUSE OF THIS REPORTED EVENT IS CURRENTLY IN PROGRESS. AS SUCH, THE PROBABLE ROOT CAUSE CANNOT YET BE DETERMINED BASED ON THE INFORMATION PROVIDED. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT DURING A DA VINCI-ASSISTED A SACROCOLPOPEXY WITH HYSTERECTOMY SURGICAL PROCEDURE, WHEN THE CUSTOMER INSERTED THE SINGLE PORT (SP) MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT INTO THE PATIENT, THE SP MCS TIP ACCESSORY SEPARATED AND FELL INTO THE PATIENT¿S ANATOMY. THE FRAGMENTS WERE RETRIEVED DURING THE SAME PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SACROCOLPOPEXY WITH HYSTERECTOMY SURGICAL PROCEDURE, WHEN THE CUSTOMER INSERTED THE SINGLE PORT (SP) MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT INTO THE PATIENT, THE SP MCS TIP ACCESSORY SEPARATED AND FELL INTO THE PATIENT¿S ANATOMY. UPON RETRIEVING THE TIP ACCESSORY AND CHECKING IT, THE CUSTOMER FOUND THE TIP CONNECTOR WAS DAMAGED. A BACKUP PRODUCT WAS USED TO CONTINUE THE PROCEDURE. THE PROCEDURE WAS CONTINUING AS PLANNED WITH NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT AND SP MCS TIP ACCESSORY WERE INSPECTED PRIOR TO USE WITH NO DAMAGE OBSERVED. THE CUSTOMER CONFIRMED THAT ONLY THE SP MCS TIP ACCESSORY FELL INSIDE OF THE PATIENT WHILE DISSECTING THE TISSUE. THE CUSTOMER WAS ABLE TO RETRIEVE THE TIP ACCESSORY DURING THE SAME PROCEDURE AND CONFIRMED WITH VISUAL INSPECTION. ADDITIONAL SURGICAL PROCEDURE AND POST-OPERATIVE TESTS WERE NOT PERFORMED. NO HOLES/TEARS/MISSING MATERIAL APPEARED PROXIMAL TO THE TIP BLADES. THE REDUCER WAS NOT USED. IT WAS UNKNOWN WHAT CAUSED THE ISSUE TO OCCUR AS THE SP MCS INSTRUMENT DID NOT COLLIDE WITH ANY HARD MATERIALS OR OTHER INSTRUMENTS. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT. THE FRAGMENT(S) DID NOT FALL INSIDE THE PATIENT DURING AN INSTRUMENT TIP OR ACCESSORY COLLISION. THE INSTRUMENT WRIST WAS STRAIGHTENED UPON REMOVAL WITH NO DIFFICULTY IN REMOVING. THE SURGICAL STAFF FOUND DAMAGE ON THE SP MCS INSTRUMENT AFTER THE EVENT OCCURRED. THE SP MCS TIP ACCESSORY WAS PROPERLY INSTALLED, AND NO ARCING WAS OBSERVED DURING THE PROCEDURE. THE PATIENT HAD NO INJURY OR HARM AND HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2305986 NONE MONOPOLAR CURVED SCISSORS (MCS) TIP NAY INTUITIVE SURGICAL, INC 430035-10 N/A

    Patients

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