BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI

    MDR report key: 11967510 · Received June 9, 2021

    Report

    Report Number
    2955842-2021-10630
    Event Type
    Injury
    Date Received
    June 9, 2021
    Date of Event
    May 11, 2021
    Report Date
    May 13, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874111045
    PMA / PMN Number
    K112263
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON A RE-EVALUATION OF THE COMPLAINT INFORMATION, THIS COMPLAINT HAS BEEN RECLASSIFIED AS AN ADVERSE EVENT AND PRODUCT PROBLEM RATHER THAN JUST A PRODUCT PROBLEM, AS PREVIOUSLY REPORTED.

    Additional Manufacturer Narrative · 0

    ON 08-JUNE-2021, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE CUSTOMER: THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT AND MS TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE. THE MS TIP COVER ACCESSORY WAS RETRIEVED WITH A LAPAROSCOPY GRASPER DURING THE PROCEDURE. NO ISSUES WERE OBSERVED WITH THE FUNCTIONALITY OF THE MCS INSTRUMENT. THE MCS INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS. THE MCS INSTRUMENT'S WRIST WAS STRAIGHTENED UPON REMOVAL, AND THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE MCS INSTRUMENT THROUGH THE CANNULA. THE SURGICAL STAFF DID NOT FIND DAMAGE ON THE MS TIP COVER ACCESSORY, MCS INSTRUMENT, OR CANNULA AFTER THE EVENT OCCURRED. THE CUSTOMER STATED THEMS TIP COVER ACCESSORY WAS PROPERLY INSTALLED WITH AN INSTALLATION TOOL, AND THERE WAS NO ORANGE SURFACE VISIBLE. THE MS TIP COVER ACCESSORY WAS NOT INSTALLED BEYOND THE ORANGE SURFACE. THE CUSTOMER DID NOT APPLY ELECTROLUBE OR ANY OTHER LUBRICANT TO THE MCS INSTRUMENT. NO SURGICAL PROCEDURES WERE REQUIRED TO REMOVE THE ITEM. NO POST-OPERATIVE TESTS WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. NO INFORMATION WAS PROVIDED PERTAINING TO THE PATIENT MEDICAL HISTORY, PRE-EXISTING MEDICAL CONDITIONS, OR TESTS/LABORATORY DATA SPECIFIC TO THE INCIDENT.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MCS TIP COVER ACCESSORY INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE REPORTED COMPLAINT WAS NOT CONFIRMED DURING FAILURE ANALYSIS. NO PHYSICAL DAMAGE WAS OBSERVED; THE TIP COVER HAD NO CUTS OR HOLES. THE MCS TIP COVER ACCESSORY WAS PROPERLY INSTALLED ON ANOTHER MCS INSTRUMENT WITHOUT ISSUE USING AN APPLICABLE TIP COVER TOOL. THE MCS TIP COVER ACCESSORY WAS NOT LOOSE NOR DID IT MOVE WHILE ATTACHED ON THE TUBE EXTENSION OF THE MCS INSTRUMENT. THE MCS INSTRUMENT WAS DRIVEN AND NO INTERFERENCE OR ISSUES OCCURRED. THE TIP COVER TOOL WAS USED PROPERLY TO REMOVE THE MCS TIP COVER ACCESSORY OFF THE INSTRUMENT. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. VERIFICATION OF THE ACCESSORY PRODUCT VIA SYSTEM LOGS CANNOT BE PERFORMED BECAUSE ACCESSORY DEVICE PRODUCT DETAILS ARE NOT CAPTURED IN THE SYSTEM LOG. THE ALLEGED COMPLAINT CANNOT BE CONFIRMED UPON REVIEW OF THE PROVIDED IMAGE. THERE WERE NO SIGNS OF TEAR(S) AT THE MOUTH ON THE CLEAR DISTAL END OR GRAY SILICONE AREA. THERE WAS NO MISSING MATERIAL SEEN. THERE WERE NO SIGNS OF THERMAL DAMAGE PRESENT. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, IT WAS ALLEGED THAT THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT. THE ITEM WAS RETRIEVED AND NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. HOWEVER, AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE MCS TIP COVER ACCESSORY TO FALL INSIDE THE PATIENT. ALTHOUGH THERE WAS NO PATIENT HARM REPORTED, IF THE REPORTED MALFUNCTION WERE TO RECUR, IT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY - RETROPERITONEAL SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY DROPPED TWICE WHEN THE ASSISTANT WAS TRYING TO REMOVE MCS INSTRUMENT. THE FIRST TIME OCCURRED ONCE THE INSTRUMENT WAS STOCKED IN THE CANNULA. SECONDLY, THE MCS TIP COVER ACCESSORY FELL INTO THE PATIENT'S ABDOMINAL CAVITY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. DUE TO THE ALLEGED ISSUE, THE PROCEDURE WAS DELAYED BY 10 MINUTES. THE CUSTOMER IS UNABLE TO RELEASE PATIENT DEMOGRAPHIC INFORMATION FOR THIS EVENT. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE REPORTED EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865204 DA VINCI TIP COVER ACCESSORY NAY INTUITIVE SURGICAL, INC 400180-14 M90201009 10886874111045

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES.| DA VINCI INSTRUMENTS AND ACCESSORIES