BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 11795470 · Received May 9, 2021

    Report

    Report Number
    2955842-2021-10489
    Event Type
    Malfunction
    Date Received
    May 9, 2021
    Date of Event
    March 10, 2021
    Report Date
    April 13, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112281
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MARYLAND BIPOLAR FORCEPS INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. VISUAL INSPECTION IDENTIFIED A BROKEN CONDUCTOR WIRE ON THE DISTAL CLEVIS. NO OTHER CABLES OR WIRES SHOWED SIGN OF DAMAGE AT THE DISTAL AREA. ELECTRICAL CONTINUITY AND OTHER TESTING WAS NOT PERFORMED DUE TO THE RECEIVED CONDITION OF THE INSTRUMENT. THE ROOT CAUSE OF THIS ISSUE IS INDICATIVE OF A COMPONENT FAILURE. AS PART OF INVESTIGATION, THE INSTRUMENT WAS FURTHER INSPECTED AFTER DISASSEMBLY OF THE HOUSING AT THE PROXIMAL END. THE CONDUCTOR WIRE INSIDE THE HEAT SHRINK TUBING WAS IDENTIFIED BROKEN. NO OTHER DAMAGE WAS FOUND ON THE PROXIMAL END. THIS SECONDARY FINDING IS ATTRIBUTED TO A MANUFACTURING ISSUE. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. NO PROCEDURE VIDEO OR IMAGE WAS SUBMITTED TO ISI FOR REVIEW. A REVIEW OF THE INSTRUMENT LOG FOR THE MARYLAND BIPOLAR FORCEPS LOT# N12200224/ SEQUENCE 0109 ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE INSTRUMENT WAS LAST USED FOR A PROCEDURE ON THE REPORTED EVENT DATE OF (B)(6) 2021 USING SYSTEM (B)(4). THE INSTRUMENT HAD 1 REMAINING USABLE LIFE WITH NO SUBSEQUENT USE RECORDED. THE MARYLAND BIPOLAR FORCEPS INSTRUMENTS ARE MULTIPLE-USE ELECTROSURGICAL ENDOSCOPIC INSTRUMENTS WITH A GRASPING TIP TO BE USED IN CONJUNCTION WITH THE DA VINCI SYSTEM AND AN EXTERNAL ELECTROSURGICAL UNIT (ESU). THE INSTRUMENT IS DESIGNED TO PROVIDE ENERGY FROM THE DESIGNATED LOCATION ON THE INSTRUMENT (THE TIP) TO THE PLANNED ANATOMICAL LOCATION WHEN USED AS INTENDED. THE ENERGY IS ACTIVATED BY PRESSING THE DESIGNATED PEDAL ON THE SURGEON SIDE CONSOLE (SSC). THIS EVENT IS BEING REPORTED REPORTED BASED ON THE FOLLOWING CONCLUSION: EVALUATION BY FAILURE ANALYSIS CONFIRMED THAT THE CONDUCTOR WIRE WAS FOUND BROKEN ON THE PROXIMAL END INSIDE THE HEAT SHRINK TUBING WITH NO EVIDENCE OF USER MISHANDLING OR MISUSE REPORTED. DAMAGE TO THE CONDUCTOR WIRE AT THIS LOCATION COULD LEAD TO UNINTENDED ELECTRICAL DISCHARGE AT A LOCATION OTHER THAN INTENDED. WHILE THERE WAS NO HARM OR INJURY TO PATIENT, THE REPORTED FAILURE MODE COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE, THE MARYLAND BIPOLAR FORCEPS INSTRUMENT CABLE BROKE. THE USER COMPLETED THE PROCEDURE USING THE BACKUP INSTRUMENT WITH NO FURTHER ISSUE REPORTED. NO ALLEGATION RELATED TO UNINTENDED ENERGY DISCHARGE TO THE PATIENT WAS REPORTED. NO FRAGMENT FELL INSIDE THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691752 ENDOWRIST MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 470172-16 N12200224 0109 00886874112281

    Patients

    Seq Age Sex Outcome Treatment
    1