BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE-SITE

    MDR report key: 16122197 · Received January 9, 2023

    Report

    Report Number
    2955842-2022-16346
    Event Type
    Injury
    Date Received
    January 9, 2023
    Date of Event
    November 21, 2022
    Report Date
    December 10, 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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER REGARDING CLIP APPLICATION FAILURE AND A FRAGMENT MAY HAVE FELL INSIDE THE PATIENT, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. ALTHOUGH THE COMPLAINT REGARDING THE ISSUE WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE INSTRUMENT WAS NOT RETURNED, THE INFORMATION GATHERED INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. INTUITIVE SURGICAL, INC. (ISI) HAS NOT YET RECEIVED THE INSTRUMENT FOR FAILURE ANALYSIS. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE COULD NOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. THE PROBABLE ROOT CAUSE OF THE CLIP APPLICATION FAILURE AND CLIP SUBSEQUENTLY FALLING INSIDE THE PATIENT IS CURRENTLY UNDETERMINED. 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. ADDITIONALLY, IT WAS ALLEGED THAT THE CLIP 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 ISSUE TO OCCUR.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT FOR EVALUATION. THE REPORTED EVENT WAS CONFIRMED DURING FAILURE ANALYSIS INVESTIGATION. THE INSTRUMENT FAILED THE CLIP TEST DUE TO MISAPPLICATION OF THE CLIP (E.G., THE INSTRUMENT PASSES ENGAGEMENT AND ABLE TO RETAIN CLIP THROUGH ENGAGEMENT BUT CANNOT APPLY THE CLIP). NO PHYSICAL DAMAGE WAS IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT ALLEGEDLY WAS UNABLE TO LOCK THE CLIP. THE USER REPLACED TO THE BACKUP INSTRUMENT AND CONTINUED THE PROCEDURE WITH NO FURTHER ISSUE REPORTED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE HOSPITAL NURSE: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO ISSUE WAS IDENTIFIED. THE INSTRUMENT INITIALLY WORKED. THE INSTRUMENT WAS UNABLE TO APPLY THE CLIP DURING ACTUAL CLIP APPLICATION. THE INSTRUMENT WAS NOT DAMAGED. THE CLIP THAT WAS INTENDED TO BE APPLIED FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE.

    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
    1424124 SINGLE-SITE CLIP APPLIER, MEDIUM-LARGE NAY INTUITIVE SURGICAL, INC 478053-04 K10220418 0001 00886874113585

    Patients

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