BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 14882208 · Received July 1, 2022

    Report

    Report Number
    2955842-2022-12706
    Event Type
    Malfunction
    Date Received
    July 1, 2022
    Date of Event
    May 30, 2022
    Report Date
    May 31, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119808
    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 · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT. FOR CLARIFICATION, THE INSTRUMENT WAS FOUND WITH DAMAGED INSULATION TO THE CONDUCTOR WIRE NEAR THE DISTAL IDLER PULLEY. MATERIAL APPEARED TO BE LIFTED OFF, EXPOSING THE BARE WIRE. NO MATERIAL APPEARED TO BE MISSING. THE ELECTRICAL CONTINUITY TEST STILL PASSED. NO THERMAL DAMAGE WAS OBSERVED. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF INSULATION DAMAGE - CONDUCTOR WIRE TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE ROOT CAUSE IS ATTRIBUTED TO A COMPONENT FAILURE FOR THE INSULATION DAMAGE TO THE CONDUCTOR WIRE. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS AVAILABLE FOR REVIEW. A SYSTEM LOG REVIEW WAS PERFORMED, BUT NO ERRORS RELATED TO THIS EVENT WOULD EXIST IN THE LOGS. A REVIEW OF THE DEVICE LOGS FOR THE FENESTRATED BIPOLAR FORCEPS (PART# 471205-17 / LOT/SERIAL# N10210712-0348) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER THIS REVIEW OF THE LOGS, THE FENESTRATED BIPOLAR FORCEPS WAS LAST USED ON 30-MAY-2022 VIA SYSTEM SERIAL# SK3675 FOR A LOW ANTERIOR RESECTION PROCEDURE. THERE WERE 10 USES REMAINING AFTER THIS LAST USAGE. THIS LAST USAGE OF THE DEVICE PER THE LOG REVIEW MATCHES THE REPORTED EVENT DATE, INDICATING THAT THE INSTRUMENT WAS NOT USED AFTER THE DATE OF THE REPORTED EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT HAD CONDUCTOR WIRE DAMAGE DURING A PROCEDURE. THE DAMAGED/BROKEN CONDUCTOR WIRE HAS POTENTIAL FOR ELECTRICAL DISCHARGE AT A LOCATION OTHER THAN INTENDED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT HAD A BROKEN CONDUCTOR WIRE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE MEDICAL ENGINEER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE BUT NO DAMAGE WAS FOUND. THE BROKEN PART WAS CONFIRMED DURING REPROCESSING UNDER VISUAL INSPECTION. THE COVER OF THE CONDUCTOR WIRE WAS FOUND DAMAGED DURING CENTRAL PROCESSING. NO PHOTOGRAPHIC IMAGES OF THE DAMAGE WERE AVAILABLE FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1609905 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-17 N10210712 0348 00886874119808

    Patients

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