BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 10516306 · Received September 10, 2020

    Report

    Report Number
    2955842-2020-10884
    Event Type
    Malfunction
    Date Received
    September 10, 2020
    Date of Event
    January 8, 2020
    Report Date
    August 17, 2020
    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 Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    4307 - INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MARYLAND BIPOLAR FORCEPS INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE INSTRUMENT WAS FOUND TO HAVE CHARRING AND LOCALIZED MELTING AT THE GRIP BASE BETWEEN THE GRIPS WHICH IS LIKELY DUE TO INSULATION DEGRADATION AND CARBONIZED TISSUE CREATING A CONDUCTIVE PATHWAY. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST AND NO DAMAGE TO THE CONDUCTOR WIRE WAS OBSERVED. NO NON-CONFORMANCES WERE IDENTIFIED. NO OTHER DAMAGE OR ABNORMALITIES WERE OBSERVED. NO PROCEDURE VIDEO OR IMAGE WAS SUBMITTED TO ISI FOR REVIEW.

    Additional Manufacturer Narrative · 0

    UPDATED INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: G4, G7, H2, H6, H10. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION ON 22-OCT-2020 REGARDING THE REPORTED EVENT. NO ISSUE RELATED TO UNINTENDED ENERGY DISCHARGE OR ARCING, AND NO NON-CONFORMANCE OR INSTRUMENT COLLISION ON THE LAST KNOWN INSTRUMENT USAGE DURING A PROCEDURE ON (B)(6) 2019 USING SYSTEM SK2437 WAS OBSERVED. AFTER THE PROCEDURE, THE INSTRUMENT WAS INSPECTED AND FOUND NO ISSUE.

    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.

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE MARYLAND BIPOLAR FORCEPS INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED. SITE HISTORY REVIEW: A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT. SYSTEM LOG INVESTIGATION: A REVIEW OF THE INSTRUMENT LOG FOR THE (B)(6) BIPOLAR FORCEPS INSTRUMENT LOT# N10181109 /SEQUENCE 0003 ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE INSTRUMENT WAS LAST USED ON (B)(6) 2019 ON SYSTEM (B)(4) USING UP ITS 4TH LIFE. THE INSTRUMENT HAS 6 REMAINING USABLE LIFE WITH NO SUBSEQUENT USE RECORDED SINCE THIS ISSUE WAS IDENTIFIED PRIOR TO STARTING THE PROCEDURE. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THE DECISION TREE WAS EXECUTED TO INDICATE THAT THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE MALFUNCTION EVENT DUE TO THE FOLLOWING CONCLUSION: 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). THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE AN MDR REPORTABLE EVENT; HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE COMPLAINT ALLEGES A BURNT INSTRUMENT PULLEY WITH NO ALLEGATION OF MISHANDLING OR MISUSE. 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. DEVICE EXPIRATION DATE WAS LEFT BLANK AS THIS INSTRUMENT HAS 10 USAGES ALLOTTED TO IT, WHICH ARE TRACKED BY THE DA VINCI SURGICAL SYSTEM. THE INSTRUMENT HAS 4 REMAINING USABLE LIVES, THEREFORE, HAD NOT EXPIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER CONDUCTED AN INSPECTION AND IDENTIFIED THAT THE MARYLAND BIPOLAR FORCEPS INSTRUMENT PULLEY WAS BURNT. PLANNED USE OF THE INSTRUMENT WAS DISCONTINUED. THE USER COMPLETED THE PROCEDURE WITH NO FURTHER ISSUE REPORTED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION RELATED TO THE EVENT HAS BEEN REQUESTED, BUT NO FURTHER DETAILS HAVE BEEN OBTAINED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979204 ENDOWRIST MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 470172-16 N10181109 0003 00886874112281

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI INSTRUMENTS AND ACCESSORIES