BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 17015755 · Received May 27, 2023

    Report

    Report Number
    2955842-2023-14881
    Event Type
    Malfunction
    Date Received
    May 27, 2023
    Date of Event
    June 21, 2021
    Report Date
    June 23, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874111045
    PMA / PMN Number
    K112263
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE TIP COVER ACCESSORY INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS DID NOT REPLICATE NOR CONFIRM THE CUSTOMER REPORTED COMPLAINT. THE TIP COVER WAS INSTALLED ON AN IN-HOUSE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT AND DRIVEN ON AN IN-HOUSE SYSTEM. THE TIP COVER DID NOT SEPARATE FROM THE INSTRUMENT DURING IN-HOUSE TESTING. THE FIT OF THE TIP COVER DID NOT FEEL LOOSE WHILE INSTALLED ON THE IN-HOUSE INSTRUMENT. THE ROOT CAUSE OF THIS FAILURE CANNOT BE TRACED TO DEVICE. ADDITIONAL OBSERVATION NOT REPORTED BY SITE WAS THAT THE TIP COVER WAS FOUND TO HAVE GOUGES. NO MATERIAL APPEARS TO BE MISSING. THE GOUGES MEASURED APPROXIMATELY 0.066" - 0.143". THE ROOT CAUSE OF THIS FAILURE IS ASSOCIATED WITH MISHANDLING/MISUSE. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELD E4 IS BLANK BECAUSE IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA. FIELDS G5 AND G7 ARE NOT APPLICABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL HYSTERECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER WAS FOUND SUDDENLY SEPARATED FROM THE INSTRUMENT. THE TIP OF THE MCS WAS NOT VISIBLE, SO THE CUSTOMER CHECKED IT IN THE PROCESS OF CHECKING WITH THE CAMERA. THE CUSTOMER REPLACED THE TIP COVER, BUT THE ISSUE PERSISTED. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT HARM, ADVERSE OUTCOME, OR INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: ONLY TWO MCS TIP COVERS WERE USED DURING THE SAME PROCEDURE. THE OTHER RETURNED MCS TIP COVERS WERE NOT USED. THE TIP COVERS BECAME LOOSE AND GOT DETACHED. HOWEVER, NO TIP COVER OR FRAGMENT FELL INSIDE OF THE PATIENT¿S ANATOMY. THERE WAS NO REPORT OF PATIENT INJURY. ARCING WAS NOT OBSERVED. ALL TIP COVER ACCESSORIES WERE INSPECTED PRIOR TO USE WITH NO DAMAGE. THE INSTALLATION TOOL AND GROUNDING PAD WERE USED. THE PAD HAD NO ISSUE OR DEFECTS. DURING THE SURGICAL, THE TIP COVER APPEARED TO BE PROPERLY INSTALLED WITH NO PART OF THE ORANGE SURFACE VISIBLE. IT WAS NOT INSTALLED BEYOND THE ORANGE SURFACE. NO ELECTROLUBE OR OTHER LUBRICANT WAS APPLIED TO THE MCS INSTRUMENT PRIOR TO THE TIP COVER INSTALLATION. THE TIP OF THE MONOPOLAR CURVED SCISSORS (MCS) WAS NOT VISIBLE DURING THE PROCEDURE, SO THE CUSTOMER CHECKED IT OUT IN THE PROCESS OF CHECKING WITH THE CAMERA. THE INSTRUMENT TIPS DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL. THE TIP COVER HAD NO DAMAGE. THE PHOTOGRAPHIC IMAGES OF THE DEVICE(S) OR A VIDEO RECORDING OF THE PROCEDURE WERE NOT AVAILABLE FOR ISI REVIEW. INFORMATION REGARDING PATIENT DEMOGRAPHICS, RELEVANT TESTING, AND MEDICAL HISTORY WERE REQUESTED; HOWEVER, THE REPORTER WAS NOT ABLE TO PROVIDE THAT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1718382 NONE TIP COVER ACCESSORY NAY INTUITIVE SURGICAL, INC 400180-14 M90210126 10886874111045

    Patients

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