BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 15911860 · Received December 2, 2022

    Report

    Report Number
    2955842-2022-15734
    Event Type
    Malfunction
    Date Received
    December 2, 2022
    Date of Event
    October 25, 2022
    Report Date
    November 6, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112465
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING CLIP APPLICATION FAILURE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A DISLODGED GRIP CABLE AT THE PROXIMAL END. THE ROOT CAUSE OF THIS FAILURE WAS ATTRIBUTED TO THE CRACKED CLAMPING PULLEYS. ADDITIONAL OBSERVATION NOT REPORTED BY SITE, WAS THAT THE INSTRUMENT WAS FOUND TO HAVE A CRACKED CLAMPING PULLEY. AS A RESULT, THE GRIP CABLE BECAME DISLODGED AT THE PROXIMAL END. THE ROOT CAUSE OF THIS FAILURE WAS TYPICALLY ATTRIBUTED TO MISHANDLING OR MISUSE. THE COMPLAINT REGARDING THE REPORTED ISSUE WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. NO IMAGE OR VIDEO WAS AVAILABLE FOR REVIEW. A REVIEW OF THE INSTRUMENT LOGS FOR THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT (PART NUMBER 470327-12/ LOT NUMBER N10191125 0126) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER THE REVIEW, THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WAS LAST USED IN A PROCEDURE ON (B)(6) 2022 VIA SYSTEM SERIAL# (B)(4). THE ALLEGED INSTRUMENT HAD 9 USES REMAINING AFTER THIS LAST USAGE. THE PROBABLE ROOT CAUSE OF A DISLODGED CABLE IS ATTRIBUTED TO A LOSS OF CABLE TENSION. A CRACKED CLAMPING PULLEY AND/OR INPUT SHAFT CAN CAUSE THE CABLE TO BECOME DISLODGED AT THE PROXIMAL END. WHEN THE CLAMPING PULLEY AND/OR INPUT SHAFT IS CRACKED, THE CABLE CAN DISLODGE AS THE INPUT COULD "SLIP" WITH RESPECT TO ITS INTERNAL SHAFT CAUSING THE LOSS OF CABLE TENSION. A CRACKED CLAMPING PULLEY AND/OR INPUT SHAFT CAN BE CAUSED BY IMPROPER CLEANING OR STERILIZATION TECHNIQUES USED DURING REPROCESSING. A DISLODGED CABLE AT THE PROXIMAL END CAN THEN RESULT IN THE CABLE BECOMING DERAILED OR LOOSE AT THE DISTAL END, WHICH MAY LEAD TO NON-INTUITIVE MOTION. THIS ISSUE CAN BE RESOLVED BY USING AN ALTERNATE INSTRUMENT TO COMPLETE THE PROCEDURE. THIS ISSUE IS ALSO CAPTURED IN THE FMEA FOR 8MM INSTRUMENTS. THIS COMPLAINT IS REPORTABLE MALFUNCTION EVENT DUE TO THE FOLLOWING CONCLUSION: PER THE DESCRIPTION OF THE COMPLAINT, THE CLIP APPLIER MAY HAVE INCURRED A FAILURE MODE THAT IS KNOWN TO IMPACT CLIP APPLICATION EFFECTIVENESS. DEFICIENCIES IN CLIP APPLICATION MAY LEAD TO INADEQUATE HEMOSTASIS. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT JAWS DID NOT CLOSE, AND THE CLIP COULD NOT BE APPLIED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. AN INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ISSUE. THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT COULD NOT APPLY THE CLIP AT ALL, THE ISSUE OCCURRED DURING PROCEDURE. THE CLIP DID NOT FALL INTO THE PATIENT. THE ISSUE WAS RESOLVED BY USING A BACKUP MEDIUM-LARGE CLIP APPLIER INSTRUMENT. THERE WAS NO PATIENT INJURY. WHEN THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WAS CHECKED OUTSIDE THE BODY, THE CUSTOMER FOUND A LOOSE CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1947006 ENDOWRIST MEDIUM-LARGE CLIP APPLIER NAY INTUITIVE SURGICAL, INC 470327-12 N10191125 0126 00886874112465

    Patients

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