BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 13285762 · Received January 18, 2022

    Report

    Report Number
    2955842-2022-10081
    Event Type
    Injury
    Date Received
    January 18, 2022
    Date of Event
    December 2, 2021
    Report Date
    December 20, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874121504
    PMA / PMN Number
    K150284
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT YET RECEIVED THE LARGE SUTURECUT NEEDLE DRIVER INSTRUMENT 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. A REVIEW OF THE INSTRUMENT LOG OF THE LARGE SUTURECUT NEEDLE DRIVER (PART # 471296-07 / LOT # N10201130-296) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED, HOWEVER NO INFORMATION WAS AVAILABLE. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS FOR THIS PRODUCT. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, IT WAS ALLEGED THE LARGE SUTURECUT NEEDLE DRIVER INSTRUMENT BROKE AND A FRAGMENT FELL INTO THE PATIENT. THE CUSTOMER WAS ABLE TO RETRIEVE THE FRAGMENT. THERE WAS NO INJURY TO THE PATIENT REPORTED, HOWEVER, UNINTENDED ITEMS FALLING INSIDE THE PATIENT MAY REQUIRE SURGICAL INTERVENTION, CONTRIBUTING TO AN ADVERSE EVENT. BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE MISSING PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. FIELD IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. FIELDS ARE NOT APPLICABLE.

    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. CORRECTED INFORMATION CAN BE FOUND THE FOLLOWING FIELD: B1, B2, AND H1: B1 UPDATED FROM "PRODUCT PROBLEM" TO "ADVERSE EVENT AND PRODUCT PROBLEM". B2 UPDATED TO "REQUIRED INTERVENTION". H1 UPDATED FROM "MALFUNCTION" TO "SERIOUS INJURY".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED VENTRAL HERNIA SURGICAL PROCEDURE, THE LARGE SUTURECUT NEEDLE DRIVER BROKE. NO ADDITIONAL DETAILS WERE PROVIDED. ON (B)(6) 2021, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING INFORMATION FROM THE NURSE. SHE WAS THE RESOURCE FOR THE ROOM, BUT WAS NOT IN THE ROOM WHEN THE INSTRUMENT BROKE. SHE DID LATER SEE THE PIECE THAT BROKE OFF AND IT APPEARED THAT ALL THE FRAGMENTS WERE RETRIEVED, BUT SHE DID NOT HAVE ANY OTHER INFORMATION. ON (B)(6) 2022, INTUITIVE SURGICAL, INC. (ISI) RECEIVED MEDWATCH MW5105895 STATING: "ROBOTIC NEEDLE DRIVER BROKE WHILE IN USE DURING A HERNIA REPAIR. FDA SAFETY REPORT ID # (B)(4)."

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948231 ENDOWRIST LARGE SUTURE CUT NEEDLE DRIVER NAY INTUITIVE SURGICAL, INC 471296-07 N10201130 296 00886874121504

    Patients

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