BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 19169084 · Received April 23, 2024

    Report

    Report Number
    2955842-2024-13680
    Event Type
    Injury
    Date Received
    April 23, 2024
    Date of Event
    March 27, 2024
    Report Date
    May 1, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112342
    PMA / PMN Number
    K150284
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE TECH AT THE FIELD STATED THAT THEY DID VISUALLY LOOK OVER THE INSTRUMENT WHEN IT WAS OPEN TO THEM. AT THE TIME THAT THEY INSPECTED THE INSTRUMENT THEY DID NOT NOTICED ANY ABNORMALITIES WITH THE INSTRUMENT. AT FIRST, THE SURGEON THOUGHT IT WAS THAT THE INSTRUMENT NEEDED TO BE RESEATED IN THE FACEPLATE OR THAT THE FACEPLATE NEEDED TO BE RESEATED TO THE ARM. WHEN THE PA WAS AT BEDSIDE, THE PA COMPLETED THESE TROUBLE SHOOTING MEASURES AND THE ISSUES STILL PERSISTED. THAT IS WHEN THE SURGEON REQUESTED A NEW INSTRUMENT. THE ISSUE WITH THE INSTRUMENT ISSUE WAS NOTICED WITHIN 5 MINUTES OF USE. THE SURGEON NOTED THAT THE INSTRUMENT FELT SLUGGISH IN ITS RESPONSE TO THE MASTERS. THERE WAS NO COLLUSION OF THE INSTRUMENT WITH ANY COMPONENTS OF THE CASE. THE NEEDLE DID FALL WHEN THE NEEDLE DRIVER LOST ITS GRIP, BUT THE NEEDLE WAS ATTACHED TO SUTURE THAT WAS ALREADY THROUGH TISSUE AND MESH. THE INSTRUMENT WAS REMOVED AFTER THE TROUBLE SHOOTING EFFORTS PROVED TO BE UNSUCCESSFUL. THE WRIST WAS STRAIGHT WHEN REMOVED FROM THE PATIENT. THE PA FELT NO RESISTANCE WHEN REMOVING THE INSTRUMENT FROM THE ARM. NO RESISTANCE WAS FELT WHEN THE INSTRUMENT WAS REMOVED. THERE WAS NO CANNULA DAMAGE PER THE TECH. THERE WASN'T ANY EXTERNAL DAMAGE TO THE INSTRUMENT, THAT WAS VISUALIZED BY THE TECH. WHEN THE SURGEON WAS FINISHED SEWING THE MESH IN PLACE, THE PA REMOVED THE NEEDLE WITH THE TECH TO VERIFY THAT IS WAS REMOVED. ALL FRAGMENTS/THE NEEDLE WAS REMOVED AND VERIFIED BY TWO COUNTS BY THE RN & TECH. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE NEEDLE. THE PROCEDURE WAS COMPLETED ROBOTICALLY. NO INJURY WAS REPORTED BY STAFF DAY OF OR PATIENT AT POST-OP CHECK BY PA. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. RELEVANT TESTS, RESULTS, AND THE DATES PERFORMED INCLUDE THE PATIENT HAVING A CT DONE ON (B)(6) 2023 THAT DIAGNOSED THE HERNIA THAT HAD OCCURRED. RELEVANT PATIENT HISTORY, INCLUDING PRE-EXISTING MEDICAL CONDITIONS INCLUDE THE PATIENT HAVING A CYSTECTOMY WITH UROSTOMY DUE TO BLADDER CANCER. THE SURGEON PREFORMED A ROBOTIC ASSISTED COMPONENT SEPARATION, MYOFASCIAL ADVANCEMENT FLAP FOR AN INCISIONAL HERNIA & PARASTOMAL HERNIA REPAIR WITH MESH. ISI DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MEGA NEEDLE DRIVER INSTRUMENT WAS ANALYZED AND REPORTED FAILURE WAS CONFIRMED. THE INSTRUMENT WAS FOUND TO HAVE A BENT GRIP AND THE TIP DOES NOT ALIGN WITH THE OTHER GRIP. THE GRIPS DO NOT SHOW CRACKING DAMAGE. COMPONENTS ADJACENT TO THIS BENT GRIP SHOW DAMAGE WHICH MAY INDICATE POTENTIAL MISHANDLING/MISUSE / DO NOT SHOW DAMAGE. UPDATED FIELDS: B6, B7.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INSTRUMENT, HOWEVER, FAILURE ANALYSIS HAS NOT COMPLETED THEIR INVESTIGATION. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN FAILURE ANALYSIS HAS COMPLETED THEIR INVESTIGATION.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA-VINCI ASSISTED PARASTOMAL HERNIA REPAIR HERNIA PROCEDURE, THE MEGA NEEDLE DRIVER INSTRUMENT WOULD NOT HOLD ONTO THE "O-STRATAFIX ON A CT-1" WHEN THE SURGEON WENT TO INSERT THE NEEDLE THROUGH TISSUE TO SECURE MESH. THIS ALLOWED THE NEEDLE TO TURN IN THE WRONG DIRECTION OR FALL COMPLETELY OUT OF THE INSTRUMENT'S JAWS. THE PROCEDURE WAS COMPLETED ROBOTICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1328926 ENDOWRIST MEGA NEEDLE DRIVER NAY INTUITIVE SURGICAL, INC 470194-08 K10230817 0165 00886874112342

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES