BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8MM TIP COVER ACCESSORY

    MDR report key: 1942613 · Received December 30, 2010

    Report

    Report Number
    2955842-2010-00562
    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 AND VARIOUS HOLES BURNED THROUGH THE SILICONE. TWO OF THE HOLES ARE ADJACENT TO EACH OTHER AND THE THIRD HOLE IS APPROXIMATELY 90 DEGREES AWAY. THE SILICONE EXHIBITS LOCALIZED MELTING AROUND THE HOLES, INDICATIVE OF ARCING. THE HOLE SIZES RANGE FROM .010 INCHES TO .030 INCHES WITH VARYING SHAPES (ROUND AND OBLONG), AND ARE LOCATED .225 INCHES TO .470 INCHES ABOVE THE SILICONE TO SLEEVE INTERFACE. THE TIP COVER ALSO HAS A MECHANICAL TEAR ADJACENT TO THE EDGE OF ONE OF THE HOLES. FAILURE ANALYSIS CONCERNING THE RETURNED TIP COVER ACCESSORY FOR THIS REPORT WAS INITIALLY PROVIDED IN MFR REPORT 2955842-2010-00563. ON (B)(6) 2010, ISI RECEIVED 2 TIP COVER ACCESSORIES, BELIEVED TO HAVE BEEN USED DURING EVENTS REPORTED IN MFR REPORT S 2955842-2010-00563 AND 2955842-2010-00561. ON (B)(6) 2011, (B)(6), STATED THAT THE SITE HAS DECIDED TO RETAIN THE TIP COVER ACCESSORY USED DURING THE EVENT REPORTED IN MEDWATCH UF / IMPORTER REPORT (B)(4) (MFR REPORT 2955842-2010-00563). A FOLLOW-UP MDR HAS BEEN SENT TO THE FDA CONCERNING MFR REPORT 2955842-2010-00563.

    Additional Manufacturer Narrative · 1

    THE TIP COVER ACCESSORY AND MCS INSTRUMENT HAVE 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 ADDITIONAL INFORMATION IS RECEIVED. 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 2955842-2010-00561 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 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