BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 10578614 · Received September 24, 2020

    Report

    Report Number
    2955842-2020-10963
    Event Type
    Malfunction
    Date Received
    September 24, 2020
    Date of Event
    August 13, 2020
    Report Date
    September 2, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112359
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT CODE: 3052 - ELECTRICAL WIRE 4307, 61 - INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. VISUAL INSPECTION IDENTIFIED DAMAGED CONDUCTOR WIRE INSULATION. THE KNOWN COMMON CAUSE OF THIS FAILURE IS ATTRIBUTED TO INSTRUMENT MISHANDLING AND MISUSE. THE INSTRUMENT WAS SUBJECTED TO ELECTRICAL CONTINUITY AND PASSED TESTING. ADDITIONALLY, FURTHER INSPECTION FOUND VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVED ON THE MAIN TUBE. THE SCRATCH MARKS MEASURING APPROXIMATELY 0.081¿ TO 0.125" ARE NOT ALIGNED WITH THE TUBE AXIS. THIS FAILURE IS MOST COMMONLY CAUSED BY INSTRUMENT MISHANDLING AND MISUSE. SITE HISTORY REVIEW: 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 FENESTRATED BIPOLAR FORCEPS INSTRUMENT LOT# N14190930 /SEQUENCE 0137 ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE INSTRUMENT WAS LAST USED ON THE REPORTED EVENT DATE (B)(6) 2020 USING SYSTEM SK0633. THE ALLEGED EVENT OCCURRED ON THE 6TH USE OF THE INSTRUMENT. THE INSTRUMENT HAS 4 REMAINING USABLE LIFE WITH NO SUBSEQUENT USE RECORDED. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: THE FENESTRATED 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). FAILURE ANALYSIS OF THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT FOUND CONDUCTOR WIRE INSULATION DAMAGE WITH A PASSED ELECTRICAL CONTINUITY TEST. ALTHOUGH THERE WAS NO ARCING REPORTED OR SEEN THROUGH ANALYSIS, AND THERE WAS NO PATIENT INJURY REPORTED, IF THIS FAILURE WERE TO RECUR, IT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT. BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. 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. IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIA REPAIR PROCEDURE, THE USER NOTED A DAMAGED CABLE ON THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT. THE INSTRUMENT WAS REPLACED WITH A BACKUP. THERE WAS NO REPORT RELATED TO UNINTENDED ENERGY DISCHARGE TO THE PATIENT. NO OTHER INFORMATION WAS PROVIDED. THE USER COMPLETED THE PROCEDURE WITH NO FURTHER ISSUE REPORTED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE; HOWEVER, NO ADDITIONAL INFORMATION WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1048448 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 470205-17 N14190930 0137 00886874112359

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI INSTRUMENTS AND ACCESSORIES