BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SNAP-FIT PADDLE BLADE ACCESSORY

    MDR report key: 3002546 · Received March 13, 2013

    Report

    Report Number
    2955842-2013-00811
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 12, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2016, ISI CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO INITIALLY REPORTED THIS EVENT FOR ADDITIONAL INFORMATION. THE CSR INDICATED THAT HE WAS PRESENT DURING THE SURGICAL PROCEDURE WHEN THE REPORTED FAILURE MODE OCCURRED. THE CSR INDICATED THAT THE SNAP-FIT SCALPEL INSTRUMENT AND SNAP-FIT PADDLE BLADE WERE INSPECTED BY THE SURGICAL STAFF PRIOR TO USE AND THERE WERE NO ISSUE NOTED. PER THE CSR, IT WAS THE SITE'S FIRST TIME UTILIZING THE SNAP-FIT SCALPEL INSTRUMENT FOR DA VINCI SURGICAL PROCEDURES. THE CSR DENIED THAT THE SNAP-FIT SCALPEL INSTRUMENT COLLIDED WITH ANY OTHER INSTRUMENTS DURING THE PROCEDURE. THE CSR INDICATED THAT AN X-RAY PERFORMED ON THE PATIENT SHOWED THE LOCATION OF THE BLADE ACCESSORY AND THE BLADE ACCESSORY WAS RETRIEVED, NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE BLADE ACCESSORY AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. THE CSR INDICATED THAT AFTER COMPLETION OF THE SURGICAL PROCEDURE, HE INSTALLED A NEW BLADE ACCESSORY OF THE SAME TYPE ONTO THE SNAP-FIT SCALPEL INSTRUMENT AND THAT HE WAS UNABLE TO REPLICATE THE REPORTED ISSUE. THE CSR INDICATED THAT THE BLADE ACCESSORY FIT PROPERLY ONTO THE SNAP-FIT SCALPEL INSTRUMENT AND THAT HE DID NOT NOTE ANY ISSUES WHEN HE INSTALLED THE BLADE ACCESSORY ONTO THE INSTRUMENT. THE CSR ALSO INDICATED THAT HIS INSPECTION OF THE INSTRUMENT AND THE INITIAL BLADE ACCESSORY FOUND NO DAMAGES. THE CSR INDICATED THAT THE ISSUE EXPERIENCED BY THE SITE MAY HAVE CAUSED BY IMPROPER INSTALLATION OF THE BLADE ACCESSORY ONTO THE INSTRUMENT. THE CSR INDICATED THAT THE SITE HAS DECLINED TO RETURN THE AFFECTED BLADE ACCESSORY AND INSTRUMENT, SINCE NO MALFUNCTION OF THE DEVICES WERE FOUND. THE CSR INDICATED THAT THE SITE REPORTED TO HIM THAT THERE WAS NO HARM TO THE PATIENT AND THE PATIENT HAS NOT EXPERIENCED ANY POST-SURGICAL COMPLICATIONS AS A RESULT OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE SNAP-FIT PADDLE BLADE ACCESSORY INSTALLED ON THE SNAP-FIT SCALPEL INSTRUMENT FELL INTO THE PATIENT. THE BLADE ACCESSORY WAS RETRIEVED AND NO OTHER FALLEN PIECES WERE REPORTED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. NO PATIENT HARM OR ADVERSE OUTCOME WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105274 SNAP-FIT PADDLE BLADE ACCESSORY ENDOSCOPIC INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400158

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DA VINCI SI SYSTEM, INSTRUMENTS, AND ACCESSORIES