BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8MM MCS TIP COVER ACCESSORY

    MDR report key: 1943068 · Received December 30, 2010

    Report

    Report Number
    2955842-2010-00561
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    November 18, 2010
    Report Date
    December 1, 2010
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TIP COVER ACCESSORY WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, THE TIP COVER WAS FOUND TO HAVE A MECHANICAL TEAR APPROXIMATELY .080 LONG AT THE DISTAL TIP OF THE SILICONE. THE TEAR IS IN THE AXIAL DIRECTION. THE TIP COVER ACCESSORY DOES NOT EXHIBIT ANY DAMAGE RELATED TO ARCING. NO OTHER DAMAGE WAS FOUND. ON (B)(6), 2010 (B)(6), (B)(6) RISK MANAGER, STATED THAT DURING A DA VINCI SI SURGICAL PROCEDURE, ARCING FROM THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WITH THE MCS TIP COVER INSTALLED WAS OBSERVED. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ON (B)(4), 2010, MEDWATCH UF / IMPORTER REPORT (B)(4) WAS RECEIVED: THE BOVIE CAUTERY UNIT COVER HAD A DEFECT IN IT. WHEN THE CAUTERY WAS ACTIVATED IT ARCED THROUGH THE DEFECT CAUSING A LACERATION OF THE PATIENT'S ILEAC VEIN. THE VEIN WAS REPAIRED. THE COVER DEVICE WAS INSPECTED PRIOR TO USE AND NO TEARS OR PUNCTURES WERE NOTED, HOWEVER, TWO ADDITIONAL EVENTS THAT DID NOT RESULT IN PATIENT HARM OCCURRED THE DAY BEFORE THIS EVENT WITH THE SAME DEVICE. ONE LOOKED LIKE A SMALL TEAR OR PUNCTURE, AND THE OTHER LOOKED LIKE A SMALL SLIT IN THE MATERIAL. THE PACKAGING WAS NOT RETAINED HOWEVER THE LOT FROM THE STORAGE AREA FOR THE SAME PRODUCT WAS C10222. MEDWATCH MFR REPORTS 2955842-2010-00562 AND 2955842-2010-00563 WERE ALSO SENT TO THE FDA REGARDING THESE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8MM MCS TIP COVER ACCESSORY ELECTROSURGICAL INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400180-10 C10222

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI SI SYS, INSTRUMENTS, ACCESSORIES, & ESU