BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 13694511 · Received March 8, 2022

    Report

    Report Number
    2955842-2022-10527
    Event Type
    Malfunction
    Date Received
    March 8, 2022
    Date of Event
    December 22, 2021
    Report Date
    February 9, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114285
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    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) RECEIVED THE MONOPOLAR CURVED SCISSORS INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS REPLICATED AND CONFIRMED THE CUSTOMER REPORTED COMPLAINT. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF BROKEN GRIP TIP TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. FOR CLARIFICATION, THE INSTRUMENT WAS FOUND TO HAVE A BROKEN GRIP AT THE DISTAL END. A PIECE APPROXIMATELY 0.099" X 0.083" WAS FOUND TO BE BROKEN OFF THE DISTAL END. THE BROKEN PIECE WAS NOT RETURNED. THE ROOT CAUSE OF BROKEN INSTRUMENT GRIPS -TIPS IS TYPICALLY ATTRIBUTE TO USER MISHANDLING OR MISUSE, SUCH AS EXCESS FORCE APPLIED TO THE INSTRUMENT JAWS. A REVIEW OF THE INSTRUMENT LOG FOR THE MONOPOLAR CURVED SCISSORS INSTRUMENT (PART # 430004-53/LOT# S10210603 0008) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE INSTRUMENT WAS LAST USED ON (B)(6) 2021, ON SYSTEM SP0081. THE INSTRUMENT HAD 11 USES REMAINING AFTER LAST USE. IN ADDITION, A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS ACKNOWLEDGED THAT A FRAGMENT WAS MISSING FROM A PORTION OF THE DEVICE THAT ENTERS THE PATIENT (DISTAL END). BASED ON THE INFORMATION PROVIDED, THERE WAS NO REPORT FROM THE CUSTOMER THAT A FRAGMENT FROM THE INSTRUMENT FELL INTO THE PATIENT DURING THE PROCEDURE. WHILE THERE WAS NO REPORT OF 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 PRIOR TO STARTING (PRE-ANESTHESIA) A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS FOUND TO HAVE BROKEN SHEATH BEFORE USE. A BACKUP INSTRUMENT OF SAME KIND WAS USED. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE WAS IDENTIFIED PRIOR TO STARTING PROCEDURE, SO THE PATIENT WAS NOT INVOLVED. THERE WAS NO REPORT OF FRAGMENTS FALLING FROM THE DEVICE WHILE USED WITHIN A PATIENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. INFORMATION REGARDING PATIENT DEMOGRAPHICS, RELEVANT TESTING, AND MEDICAL HISTORY WERE REQUESTED HOWEVER, THE REPORTER WAS NOT ABLE TO PROVIDE THAT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1287336 ENDOWRIST SP MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 430004-53 S10210603 0008 00886874114285

    Patients

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