BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 11102054 · Received December 31, 2020

    Report

    Report Number
    2955842-2020-11431
    Event Type
    Malfunction
    Date Received
    December 31, 2020
    Date of Event
    October 28, 2020
    Report Date
    December 10, 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

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE REPORTED EVENT WAS CONFIRMED THROUGH FAILURE ANALYSIS INVESTIGATION. VISUAL INSPECTION IDENTIFIED DAMAGED CONDUCTOR WIRE INSULATION. THE INSTRUMENT WAS TESTED AND PASSED ELECTRICAL CONTINUITY. 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 FENESTRATED BIPOLAR FORCEPS INSTRUMENT LOT# N13200113 /SEQUENCE 0428 ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE INSTRUMENT WAS LAST USED FOR A PROCEDURE ON (B)(6) 2020 USING DA VINCI SYSTEM SK0633. THE INSTRUMENT HAD 1 REMAINING LIFE WITH NO SUBSEQUENT USE RECORDED. THE CUSTOMER REPORTED EVENT STATED THE ISSUE WAS OBSERVED DURING REPROCESSING ON (B)(6) 2020. THIS INFORMATION INDICATES THAT THE INSTRUMENT WAS REPROCESSED THE SAME DAY AFTER THE PROCEDURE. 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). THIS COMPLAINT IS A REPORTABLE EVENT BASED ON THE FOLLOWING: IT WAS REPORTED THAT DURING CENTRAL PROCESSING, INSPECTION IDENTIFIED DAMAGE ON THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT CABLE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE AN MDR REPORTABLE EVENT; HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE 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 RESULT IN AN ADVERSE EVENT. 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 HAD 1 REMAINING USABLE LIFE, THEREFORE, HAD NOT EXPIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, INSPECTION IDENTIFIED DAMAGE ON THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT CABLE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: NO REPORTED INSTRUMENT ISSUE WAS OBSERVED WHEN THE INSTRUMENT WAS LAST USED FOR A PROCEDURE ON (B)(6) 2020 USING DA VINCI SYSTEM SK0633.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1564689 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 470205-17 N13200113 0428 00886874112359

    Patients

    Seq Age Sex Outcome Treatment
    1