BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8MM MCS TIP COVER ACCESSORY

    MDR report key: 2884101 · Received December 21, 2012

    Report

    Report Number
    2955842-2012-01414
    Event Type
    Injury
    Date Received
    December 21, 2012
    Report Date
    August 2, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ISI HAS CONTACTED THE INITIAL REPORTER CONCERNING THE REPORTED EVENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS PROVIDED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, DR. (B)(6) AT (B)(6) HOSPITAL IN (B)(6) FORWARDED TO INTUITIVE SURGICAL AN ARTICLE, TITLED ROBOTIC INSTRUMENT INSULATION FAILURE: INITIAL REPORT OF A POTENTIAL SOURCE OF PATIENT INJURY PUBLISHED BY DR. (B)(6). THE ARTICLE ALLEGES THAT FROM (B)(6) 2008 - (B)(6) 2009, 12 MCS TIP COVER ACCESSORIES, INSTALLED ON THE MONOPOLAR CURVED SCISSORS INSTRUMENTS FAILED INTRA-OPERATIVELY DURING DA VINCI ROBOTIC PROCEDURES AND WITH 3 OF THE TIP COVER FAILURES RESULTING IN PATIENT INJURIES. THE FOLLOWING DETAILS CONCERNING THE SECOND PATIENT INJURY AS INDICATED IN THE ARTICLE IS AS FOLLOWS: DURING A DA VINCI UROLOGICAL PROCEDURE, WHILE PERFORMING A RETROPERITONEAL LYMPHADENECTOMY USING THE MONOPOLAR CURVED SCISSORS INSTRUMENT WITH THE MCS TIP COVER INSTALLED, THE PATIENT'S SMALL BOWEL WAS INJURED. DAMAGE TO AFFECTED AREA WAS RECOGNIZED IMMEDIATELY AND WAS REPAIRED BY REAPPROXIMATION OF THE SEROSA USING A SILK SUTURE. INSPECTION OF THE TIP COVER ACCESSORY BY THE SITE FOUND THAT THE TIP COVER EXHIBITED A HOLE AT THE JUNCTION OF THE SILICON AND GRAY PLASTIC SHAFT ON THE TIP COVER. PER THE INFORMATION INDICATED IN THE REPORT, THE TIP COVER ACCESSORY WAS INSPECTED PRIOR TO USE, WAS INSTALLED ON THE MCS INSTRUMENT USING THE TIP COVER INSTALLATION TOOL WITH NO OBVIOUS MECHANICAL IMPERFECTIONS OBSERVED IN THE TIP COVER. NO OTHER DETAILS CONCERNING THE PATIENT WERE PROVIDED. MEDWATCH REPORT 2955842-2008-01353 WAS SUBMITTED TO THE FDA CONCERNING THE FIRST PATIENT INJURY AND MEDWATCH REPORT 2955842-2012-01412 WAS SUBMITTED FOR THE THIRD REPORT OF A PATIENT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DAVINCI S SURG SYSTEM, INSTRUMENT AND ACCESSORIES