BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOPOLAR CURVED SCISSORS TIPCOVER ACCESSORY

    MDR report key: 3250839 · Received July 29, 2013

    Report

    Report Number
    2955842-2013-02784
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 28, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE TIP COVER HAS NOT BEEN RETURNED FOR EVALUATION, THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE ACCESSORY IS RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) CONTACTED THE INITIAL REPORTER (A NURSE) OF THIS COMPLAINT AND OBTAINED INFORMATION REGARDING THE REPORTED EVENT. THE NURSE INDICATED THAT THE SURGICAL STAFF REGULARLY USES ELECTRO LUBE. THE NURSE WAS INSTRUCTED TO VERIFY PROPER USE OF THE ELECTRO LUBE. DURING THE SURGICAL PROCEDURE, TWO PATIENT SIDE MANIPULATORS (PSM) WERE IN USE. THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART (PSC) THAT PROVIDES STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENT. ISI HAS MADE SEVERAL ATTEMPTS 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 SURGEON INDICATED THAT THE MCS TIP COVER ACCESSORY FELL OFF THE MCS INSTRUMENT. THE TIP COVER FELL INTO THE PATIENT BUT WAS RETRIEVED. HOWEVER, AT THIS TIME IT IS UNKNOWN HOW THE TIP COVER WAS RETRIEVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE SURGICAL STAFF OBSERVED THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY INSTALLED ON AN MCS INSTRUMENT FALL OFF AND INTO THE PATIENT'S PELVIC CAVITY. THE MCS TIP COVER ACCESSORY WAS RETRIEVED AND THE SURGICAL PROCEDURE WAS COMPLETED. NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352699 MONOPOLAR CURVED SCISSORS TIPCOVER ACCESSORY ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400180

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI SI SURG SYS INST., ACCESSORIES, & ESU