BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 22778597 · Received August 11, 2025

    Report

    Report Number
    2955842-2025-33659
    Event Type
    Malfunction
    Date Received
    August 11, 2025
    Date of Event
    July 16, 2025
    Report Date
    July 17, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119808
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO EVALUATE THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT, HOWEVER, INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE REPORTED FAILURE MODE HAS NOT YET BEEN DETERMINED. A REVIEW OF THE IMAGE AND VIDEO ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. FROM THE VIDEO AND PHOTO, IT WAS CONFIRMED THAT AN UNSPECIFIED TISSUE TYPE IS CAUGHT BETWEEN THE MAIN TUBE AND CLEVIS OF THE FBF. IT DOES NOT APPEAR THAT THE STAFF TOOK MEASURES TO INTERVENE OR REPAIR TISSUE DUE TO ANY TISSUE INJURY, NO HARM IS SHOWN HERE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC., (ISI) DID RECEIVE THE 8MM FENESTRATED BIPOLAR FORCEPS INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS ANALYZED AND IT WAS FOUND TO HAVE A BENT GRIP, CAUSING A MISALIGNMENT AND ENTRAPMENT OF TISSUE. THERE WAS A .205¿ OFFSET AT THE TIPS. THE GRIPS DO NOT SHOW CRACKING DAMAGE. ADDITIONAL FINDINGS : THERE WAS A DAMAGED GRIP CABLE AT THE DISTAL END. THE PROBABLE ROOT CAUSE OF BENT GRIPS IS ATTRIBUTED TO DAMAGE DURING USE, AS MODERATE MISALIGNMENT OF GRIP TIPS CAN BE DUE TO GRASPING EITHER HARD TISSUE/OBJECTS OR COLLISIONS WITH OTHER INSTRUMENTS. THE PROBABLE ROOT CAUSE OF CABLE BREAKAGE, WHETHER PARTIAL OR FULL, IS ATTRIBUTED TO DAMAGE TO THE CABLE THROUGH EXTERNAL COLLISIONS, DURING USE, OR DURING REPROCESSING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, WHEN THE INTESTINE WAS BEING COMPRESSED WITH THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT, TISSUE WAS CAUGHT AT THE TIP OF THE SHAFT (THE JOINT BETWEEN THE RESIN AND METAL) AND COULD NOT BE REMOVED. THE ASSISTANT CAREFULLY REMOVED IT WITH LAPAROSCOPIC FORCEPS, AND NO HEALTH DAMAGE OCCURRED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1903872 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-19 K17240919 0129 00886874119808

    Patients

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