BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE-SITE

    MDR report key: 15263452 · Received August 20, 2022

    Report

    Report Number
    2955842-2022-13565
    Event Type
    Injury
    Date Received
    August 20, 2022
    Date of Event
    July 22, 2022
    Report Date
    July 21, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874113585
    PMA / PMN Number
    K152448
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS DID NOT REPLICATE NOR CONFIRM THE CUSTOMER REPORTED COMPLAINT ¿AFTER IT WENT INTO A CANNULA, CLIP WAS FALLEN OFF(DETACHED).¿ FAILURE ANALYSIS FOUND THE PRIMARY FINDING OF COULD NOT REPRODUCE - CANNOT VERIFY EXTERNAL EVENT TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. THE INSTRUMENT WAS FULLY FUNCTIONAL. ADDITIONAL STEPS/TEST ATTEMPTS TO FURTHER SUPPORT COULD NOT REPRODUCE FINDING WAS THAT VISUAL INSPECTION OF THE INSTRUMENT FOUND NO PHYSICAL OR COSMETIC DAMAGE ON THE DISTAL END. THE HOUSING WAS REMOVED FROM THE BACK END, NO DAMAGE WAS FOUND. A CLIP TEST WAS PERFORMED MULTIPLE TIMES WHILE THE INSTRUMENT WAS INSTALLED ON AN IN-HOUSE SYSTEM AND PASSED EACH TIME. THERE WAS NO PROBLEM DETECTED. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. NO IMAGE/VIDEO INVESTIGATION REQUIRED AS NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. A REVIEW OF THE INSTRUMENT LOG FOR THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT (PART# 478053-04/ LOT/SERIAL# (B)(4) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER THIS REVIEW OF THE LOGS, THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WAS LAST USED ON 22-JUL-2022 VIA SYSTEM SERIAL# (B)(4). THERE WERE 68 USES REMAINING AFTER THIS LAST USAGE. A REVIEW OF THE RFE PROCEDURE LOG SHOWED THE SITE PERFORMED THIS CHOLECYSTECTOMY SURGICAL PROCEDURE ON 22-JUL-2022 VIA SYSTEM SERIAL# (B)(4). THIS EVENT IS BEING REPORTED BECAUSE IT WAS ALLEGED THAT THE CLIP FROM THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT FELL INSIDE THE PATIENT DURING A DA VINCI ASSISTED PROCEDURE. THE CLIP WAS RETRIEVED DURING THE SAME PROCEDURE WITH NO PATIENT INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE CLIP FELL INTO THE PATIENT¿S CAVITY AFTER THE CUSTOMER INSERTED THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT INTO THE CANNULA. THE CLIP 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 ABNORMALITY. AS SOON AS THE CUSTOMER INSERTED THE INSTRUMENT THROUGH THE CANNULA, THE MEDIUM-LARGE CLIP FELL INTO THE PATIENT. THE CLIP WAS RETRIEVED RIGHT AWAY AND CONFIRMED WITH VISUAL INSPECTION. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. THE SURGEON ALLEGED THAT THE INSTRUMENT WAS MALFUNCTION AND CAUSING THE ISSUE. THE VESSEL WAS LESS THAN 10 MM IN DIAMETER. THERE WAS NO ISSUE WITH FUNCTIONALITY OF THE INSTRUMENT (E.G. NON INTUITIVE MOTION, CLIPPING, BROKEN/LOOSE CABLE..). UPON FINAL REMOVAL OF THE INSTRUMENT, THE WRIST WAS ALSO 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 INTUITIVE SURGICAL, INC. (ISI) REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301852 SINGLE-SITE CLIP APPLIER, MEDIUM-LARGE NAY INTUITIVE SURGICAL, INC 478053-04 N10210728 0035 00886874113585

    Patients

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