BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 21556160 · Received March 9, 2025

    Report

    Report Number
    2955842-2025-05759
    Event Type
    Malfunction
    Date Received
    March 9, 2025
    Date of Event
    January 29, 2025
    Report Date
    February 10, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114339
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE BIPOLAR INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN MOLDED INSULATOR. A BROKEN PIECE, MEASURING APPROXIMATELY 9.23MM X 3.66MM IN SIZE, WAS NOT RETURNED WITH THE INSTRUMENT. AS A RESULT, A DISLODGED GRIP TIP IS OBSERVED, BUT WAS STILL ATTACHED TO THE INSTRUMENT THROUGH THE CONDUCTOR WIRE. ADDITIONAL OBSERVATION RELATED TO THE CUSTOMER REPORTED COMPLAINT: DUE TO THE BROKEN MOLDED INSULATOR, A DETACHED FRAGMENT IS OBSERVED AND WAS NOT RETURNED WITH THE INSTRUMENT. THE GRIP WITH THE BROKEN MOLDED INSULATOR WAS REMOVED FROM THE INSTRUMENT AND WAS TRANSFERRED TO DESIGN ENGINEERING FOR FURTHER ANALYSIS AT A THIRD PARTY LAB. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO DAMAGE DURING USE, WHICH MAY RESULT FROM APPLYING EXCESS FORCE ON THE INSTRUMENT TIP DURING HANDLING, INSERTION, USAGE (OVERLOADING), OR REMOVAL.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE BIPOLAR INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A GRIP WITH THE BROKEN MOLDED INSULATOR WAS SENT TO A THIRD PARTY FOR FURTHER TESTING ALONG WITH 4 OTHER RMA GRIPS (2 AT CLOSE TO BEGINNING OF LIFE, AND 2 CLOSE TO END OF LIFE), 2 UNUSED GRIPS, AND THE RAW PLASTIC PELLETS. THE SAMPLES WERE NOT RETURNED. THE SAMPLES UNDERWENT THE TESTING OUTLINED IN THE ATTACHED "C0QWL665_SUMMARY.PDF" REPORT AND INCLUDED OPTICAL MORPHOLOGY COMPARISON, SEM (SCANNING ELECTRON MICROSCOPY) EXAMINATION OF FRACTURE SURFACES, TGA (THERMOGRAVIMETRIC ANALYSIS) TO COMPARE DEGRADATION PROFILES AND INORGANIC CONTENT, AND DSC (DIFFERENTIAL SCANNING CALORIMETRY) TO COMPARE THERMAL PROPERTIES. THE TESTING WAS DONE TO SAMPLES OF VARYING NUMBER OF USES IN AN ATTEMPT TO DETERMINE THE REASON FOR THE BREAKAGE AND TO SEE IF THE NUMBER OF USES HAD AN EFFECT. THE ANALYSIS FOUND: "PPA OVERMOLD MATERIAL IN FAILED/USED PARTS EXHIBITED DEGRADATION DURING CUSTOMER USE, WHICH LED TO EMBRITTLEMENT AND REDUCED MECHANICAL PROPERTIES. DUE TO THE REPORTEDLY LOW FAILURE RATE ACROSS MULTIPLE LOT FAILURE OF THE PPA OVERMOLD IS MOST LIKELY DUE TO A COMBINATION OF CHEMICAL DEGRADATION FROM REPROCESSING AND REPEATED MECHANICAL STRESS (E.G., IMPACT, TORSION, AND/OR SHEAR)." THE FINDINGS APPEAR TO SUPPORT A ROOT CAUSE OF USER AND MENTION EMBRITTLEMENT POTENTIALLY DUE TO REPROCESSING, AND BREAKAGE POTENTIALLY DUE TO REPEATED MECHANICAL STRESSES. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO DAMAGE DURING USE, WHICH MAY RESULT FROM APPLYING EXCESS FORCE ON THE INSTRUMENT TIP DURING HANDLING, INSERTION, USAGE (OVERLOADING), OR REMOVAL. THIS ISSUE CAN BE RESOLVED BY USING AN ALTERNATE INSTRUMENT TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED, THE JAWS OF THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WERE BROKEN. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SITE WAS NOT ALLOWED TO SHARE THE PATIENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232440 ENDOWRIST SP FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 430011-57 K10240118 0005 00886874114339

    Patients

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