BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 15286993 · Received August 24, 2022

    Report

    Report Number
    2955842-2022-13641
    Event Type
    Malfunction
    Date Received
    August 24, 2022
    Date of Event
    July 25, 2022
    Report Date
    July 25, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K150837
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE SMALL CLIP APPLIER (SCA) 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 DEVICE LOGS FOR THE SCA INSTRUMENT (PART# 470401-06 / LOT# T10200312 - 0094) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER THIS REVIEW OF THE LOGS, THE INSTRUMENT WAS LAST USED ON (B)(6) 2022 VIA SYSTEM SERIAL# (B)(4) FOR A DISTAL GASTRECTOMY PROCEDURE. THERE WERE 8 USES REMAINING AFTER THIS LAST USAGE. REVIEW OF THE PROVIDED IMAGE CANNOT VERIFY THE ALLEGED COMPLAINT. HOWEVER, THE INSTRUMENT INFORMATION WAS CONFIRMED UPON REVIEWING THE IMAGE. ROOT CAUSE OF THE FAILURE MODE CANNOT BE CONFIRMED WITHOUT THE RETURNED DEVICE. THIS COMPLAINT IS CONSIDERED A REPORTABLE MALFUNCTION DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED DURING A DA VINCI-ASSISTED DISTAL GASTRECTOMY SURGICAL PROCEDURE, THE JAW OF A SMALL CLIP APPLIER INSTRUMENT SWUNG SIDEWAY AND THE SURGEON COULD NOT APPLY THE CLIP. UNINTUITIVE MOTION COULD LEAD TO SUBSEQUENT TISSUE DAMAGE. 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.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HORIZONTAL SMALL CLIP APPLIER INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS REPLICATED AND CONFIRMED THE REPORTED COMPLAINT. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF BROKEN INPUT DISKS TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE MULTIPLE INPUT DISKS BOTH BROKEN AND CRACKED. INPUT DISK #7 WAS FOUND COMPLETELY DETACHED FROM THE BASE OF THE HOUSING. THE BROKEN INPUT DISK WAS RETURNED WITH THE INSTRUMENT. HAIRLINE CRACKS WERE FOUND ON GRIP INPUT SHAFT #6. NO CABLES SHOWED ANY SIGNS OF FRAYING OR BREAKAGE. AS A RESULT, THE INSTRUMENT COULD NOT ENGAGE PROPERLY WITH THE STERILE ADAPTERS ON THE IN-HOUSE SYSTEM AND LOST INTUITIVE MOTION FUNCTIONALITY. NO CLIP TEST COULD BE PERFORMED. THE ROOT CAUSE OF THE FAILURE WAS TYPICALLY ATTRIBUTED TO MISHANDLING OR MISUSE, MOST COMMONLY CAUSED BY IMPROPER CLEANING/REPROCESSING TECHNIQUES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED DISTAL GASTRECTOMY SURGICAL PROCEDURE, A CUSTOMER REPORTED THAT A SMALL CLIP APPLIER (SCA) INSTRUMENT WRIST SUDDENLY BENT AND THE SURGEON COULD NOT APPLY THE CLIP. THE CUSTOMER COULD NOT REMOVE THE SCA INSTRUMENT FROM THE UNIVERSAL SURGICAL MANIPULATOR (USM). THE RELEASE BUTTON DID NOT WORK. EVENTUALLY, THE CUSTOMER COULD REMOVE THE SCA INSTRUMENT FROM THE USM FORCEFULLY. IT WAS SUSPECTED THAT THE DISC OF THE SCA INSTRUMENT WAS DAMAGED. NO DAMAGE TO THE BLOOD VESSELS AND NO BLEEDING WERE REPORTED. THE SURGEON WAS CONCERNED THAT THE ANESTHESIA TIME EXTENSION WOULD CAUSE BURDEN TO THE PATIENT¿S HEALTH. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS NOT INSPECTED PRIOR TO USE. THERE WAS BURDEN ON THE PATIENT DUE TO THE EXTENDED ANESTHESIA TIME, HOWEVER, THERE WAS NO MEDICAL INTERVENTION. NO BLOOD VESSELS WERE INJURED. WHEN THE TARGETED BLOOD VESSEL WAS PLACED INSIDE THE CLIP AND TRIED TO BE CLIPPED, THE JAW SWUNG SIDEWAY AND GRAZED THE BLOOD VESSEL. AS A RESULT, THE CLIP WAS DISLODGED FROM THE VESSEL. THERE WAS NO FRAGMENT FALLING INSIDE THE PATIENT¿S ANATOMY. THERE WAS NO BLEEDING AND NO INTERVENTION PERFORMED DUE TO THE GRAZED BLOOD VESSEL.

    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
    2063714 ENDOWRIST CLIP APPLIER, SMALL, HORIZON NAY INTUITIVE SURGICAL, INC 470401-06 T10200312 0094

    Patients

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