BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERMANENT CAUTERY HOOK INSTRUMENT

    MDR report key: 3332386 · Received September 9, 2013

    Report

    Report Number
    2955842-2013-03413
    Event Type
    Other
    Date Received
    September 9, 2013
    Date of Event
    July 31, 2013
    Report Date
    August 9, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE REPORTED PORT SITE BURN CANNOT BE DETERMINED. THE PERMANENT CAUTERY HOOK INSTRUMENT INVOLVED WITH THIS COMPLAINT WAS RETURNED TO INTUITIVE SURGICAL INC. (ISI) AND EVALUATED BY FAILURE ANALYSIS. UPON MICROSCOPIC INSPECTION, FAILURE ANALYSIS NOTED THAT A SMALL PIECE OF THE YAW PULLEY BENEATH THE CERAMIC SLEEVE WAS FOUND TO BE MELTED OR REMOVED. THE AREA WAS NO LONGER SMOOTH AND SLIGHT CHAR MARKS WERE OBSERVED AT THE AREA. INTUITIVE SURGICAL INC. (ISI) HAS ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE SURGICAL STAFF CLAIMED THAT THE PATIENT SUSTAINED A BURN AT THE PORT SITE DURING A DA VINCI SI SURGICAL PROCEDURE. HOWEVER, AT THIS TIME, IT IS UNKNOWN HOW THE INJURY OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI UMBILICAL HERNIA REPAIR PROCEDURE, THE SURGICAL STAFF INDICATED THAT UPON REMOVAL OF THE PERMANENT CAUTERY HOOK INSTRUMENT FROM THE TROCAR, A BURN WAS OBSERVED ON THE PORT SITE. THE SURGICAL PROCEDURE WAS COMPLETED AND NO ADVERSE OUTCOME WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445414 PERMANENT CAUTERY HOOK INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420183-06 M10130521 425

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES