BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE-SITE

    MDR report key: 14810925 · Received June 24, 2022

    Report

    Report Number
    2955842-2022-12390
    Event Type
    Injury
    Date Received
    June 24, 2022
    Date of Event
    May 25, 2022
    Report Date
    May 25, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874113608
    PMA / PMN Number
    K152448
    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

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE CADIERE FORCEPS 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 PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. A REVIEW OF THE INSTRUMENT LOG FOR THE CADIERE FORCEPS INSTRUMENT (PART# 478055-04/ LOT/SERIAL# (B)(4)) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER THIS REVIEW OF THE LOGS, THE CADIERE FORCEPS INSTRUMENT WAS LAST USED ON (B)(6) 2022 VIA SYSTEM SERIAL# (B)(4). THERE WERE 4 USES REMAINING AFTER THIS LAST USAGE. A REVIEW OF THE RFE PROCEDURE LOG SHOWED THE SITE PERFORMED THIS MYOMECTOMY SURGICAL PROCEDURE ON (B)(6) 2022 ON SYSTEM SERIAL# (B)(4). THIS EVENT IS BEING REPORTED BECAUSE A PIN FROM THE INSTRUMENT FELL INSIDE THE PATIENT DURING A DA VINCI ASSISTED PROCEDURE. THE PIN WAS RETRIEVED DURING THE SAME PROCEDURE. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE PIN TO BECOME DISLODGED FROM THE INSTRUMENT.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE CADIERE FORCEPS INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE REPORTED COMPLAINT. FOR CLARIFICATION, THE INSTRUMENT WAS FOUND TO HAVE THE CLEVIS BROKEN. NO PIECES APPEARED TO BE MISSING AT THE CLEVIS. AS A RESULT, THE CLEVIS PIN WAS ABLE TO POP OUT SINCE IT IS NO LONGER SECURED. CLEVIS PIN WAS ABLE TO BE PUT BACK IN THE HOLE OF THE CLEVIS. ROOT CAUSE OF THIS FAILURE IS TYPICALLY ATTRIBUTED TO MISHANDLING/MISUSE, SUCH AS EXCESS FORCE APPLIED TO THE DISTAL END OF THE INSTRUMENT. NOTE: DURING FAILURE ANALYSIS ON 19-JUL-2022, THE CLEVIS PIN POPPED OUT OF THE CLEVIS HOLE AND WAS LOST. THE CLEVIS ALSO BROKE APART. THE FRAGMENTS OF THE CLEVIS WERE ABLE TO BE RETRIEVED AND TAPED BACK ONTO THE INSTRUMENT. CLEVIS PIN CANNOT BE FOUND. PICTURE IS ATTACHED WITH THE CLEVIS PIN BROUGHT BACK WITH THE INSTRUMENT PRIOR TO LOSING THE COMPONENT. THE CLEVIS PIN WAS LATER FOUND AFTER A THOROUGH SEARCH OF THE WORKSTATION. CLEVIS PIN IS TAPED BACK ON THE INSTRUMENT. AS STATED PREVIOUSLY, THERE WERE NO MISSING PIECES OR FRAGMENTS, PRIOR TO LOSING THE CLEVIS PIN AT INTUITIVE. UPDATE: CLEVIS PIN WAS FOUND AFTER A THOROUGH SEARCH OF THE WORKSTATION. CLEVIS PIN WAS TAPED BACK ON THE INSTRUMENT. AS STATED PREVIOUSLY, THERE WERE NO MISSING PIECES OR FRAGMENTS, PRIOR TO LOSING THE CLEVIS PIN HERE AT ISI.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CADIERE FORCEPS INSTRUMENT WAS FOUND TO HAVE THE SCREW SEPARATED WHILE BEING USED FOR SUTURING. THE SCREW FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE OBSERVED. THE INSTRUMENT WAS IN USE FOR ABOUT 20 MINUTES THEN BROKE. ALL THE FRAGMENTS WERE RETRIEVED DURING SAME PROCEDURE AND CONFIRMED WITH VISUAL INSPECTION. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. IT WAS UNKNOWN WHAT CAUSED THE BREAKAGE TO OCCUR AS THE INSTRUMENT DID NOT COLLIDE WITH ANY HARD MATERIALS OR OTHER INSTRUMENTS. THERE WAS NO PATIENT INJURY. 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 WAS NOT REMOVED DURING THE PROCEDURE (PRIOR TO THE BREAKAGE). UPON FINAL REMOVAL OF THE INSTRUMENT, THE WRIST WAS STRAIGHTENED, AND THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. BOTH INSTRUMENT AND CANNULA HAD NO OTHER DAMAGE AFTER THE EVENT OCCURRED. NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. PHOTOGRAPHIC IMAGES OF THE DEVICE(S) OR A VIDEO RECORDING OF THE PROCEDURE WERE NOT AVAILABLE FOR ISI REVIEW.

    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
    1070875 SINGLE-SITE CADIERE FORCEPS NAY INTUITIVE SURGICAL, INC 478055-04 N10210823 0006 00886874113608

    Patients

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