BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE-SITE

    MDR report key: 15341258 · Received September 1, 2022

    Report

    Report Number
    2955842-2022-13798
    Event Type
    Injury
    Date Received
    September 1, 2022
    Date of Event
    July 29, 2022
    Report Date
    August 3, 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
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE MEDIUM-LARGE CLIP APPLIER FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN FAILURE ANALYSIS HAS COMPLETED THEIR INVESTIGATION. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. 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. THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WAS LAST USED ON (B)(6) 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 (B)(6) 2022 VIA SYSTEM SERIAL# (B)(4). THIS COMPLAINT IS CONSIDERED A REPORTABLE MALFUNCTION 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. FURTHERMORE, THE CLIP OF 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. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE BREAKAGE TO OCCUR. 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 MEDIUM-LARGE CLIP APPLIER INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS REPLICATED AND CONFIRMED THE CUSTOMER REPORTED COMPLAINT "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WAS FOUND TO HAVE GRIP FAILURE. THE INSTRUMENT DID NOT ENGAGE WITH THE CLIP WELL." FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF FAILED CLIP TEST 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 MEDIUM-LARGE CLIP APPLIER INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIP CLIP TEST WAS PERFORMED AND FAILED MULTIPLE TIMES. THE CLIP WAS UNABLE TO SUCCESSFULLY CLIP ONTO THE TUBING AFTER MULTIPLE ATTEMPTS. THE ROOT CAUSE WAS NOT DETERMINABLE. AN ADDITIONAL OBSERVATION NOT REPORTED BY THE SITE WAS THAT THE INSTRUMENT MAIN TUBE WAS FOUND TO BE BENT. THE BENDING DAMAGE IS LOCATED AROUND THE MIDDLE OF THE MAIN TUBE. THE ROOT CAUSE OF BENT INSTRUMENT MAIN TUBE IS TYPICALLY ATTRIBUTED TO MISHANDLING/MISUSE, SUCH AS EXCESSIVE LOADING, OR IMPROPER HANDLING DURING TRANSPORT.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FURTHER INVESTIGATED AND TESTED THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT. THE INITIAL FAILURE ANALYSIS WAS WERE CONFIRMED. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE SYSTEM AND FAILED THE CLIP TEST. THE HOUSING WAS THEN REMOVED AND IT WAS FOUND THAT THE SCREW AT THE ROCKER WHICH HOLDS THE PUSH-PULL ROD ASSEMBLY WAS LOOSE. THE LOOSE SCREW LIKELY CAUSED THE PUSH-PULL ROD ASSEMBLY TO BE UNSECURED AND THUS, UNABLE TO GENERATE ENOUGH FORCE TO COMPLETE CLIP APPLICATION. THE ROOT CAUSE OF THIS IS ATTRIBUTED TO A COMPONENT FAILURE. IT IS LIKELY THAT THE ADDITIONAL FRICTION GENERATED FROM THE BENT MAIN TUBE ALSO CONTRIBUTED TO THE CLIP APPLICATION FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WAS FOUND TO HAVE GRIP FAILURE. THE INSTRUMENT DID NOT ENGAGE WITH THE CLIP WELL. A BACKUP INSTRUMENT OF A DIFFERENT TYPE WAS USED TO CONTINUE THE PROCEDURE. THE CLIP WAS RETRIEVED DURING THE SAME PROCEDURE WITH NO PATIENT INJURY. THE PROCEDURE WAS COMPLETED. 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. DURING CLIP APPLICATION, THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT COULD HOLD THE CLIP, BUT IT COULD NOT CLOSE ON THE VESSEL THAT WAS LESS THAN 10 MM IN DIAMETER. AS SOON AS THE CUSTOMER USED THE INSTRUMENT, THE CLIP FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. IT WAS CONFIRMED WITH VISUAL INSPECTION. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. THERE WAS NO OTHER ISSUE WITH FUNCTIONALITY OF THE INSTRUMENT (E.G. NON INTUITIVE MOTION, BROKEN/LOOSE CABLE). THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE (PRIOR TO THE BREAKAGE). 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. POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND WERE NOT PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PATIENT HAD NO INJURY/HARM AND HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    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
    1201150 SINGLE-SITE CLIP APPLIER, MEDIUM-LARGE NAY INTUITIVE SURGICAL, INC 478053-04 N10211116 0005 00886874113585

    Patients

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