BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3140450 · Received May 31, 2013

    Report

    Report Number
    2955842-2013-01944
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 10, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION, THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. IT IS UNKNOWN IF THE MCS INSTRUMENT HAS BEEN USED IN ANY SUBSEQUENT SURGICAL PROCEDURES AFTER THE REPORTED EVENT OCCURRED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST ENGINEERING EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. ON (B)(4) 2013, THE INITIAL REPORTER PROVIDED ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT. THE INITIAL REPORTER INDICATED THAT ON (B)(6) 2013 THE PATIENT PRESENTED SYMPTOMS OF PAIN AND FEVER. A CT SCAN PERFORMED SHOWED THAT THE PATIENT HAD AIR AROUND THE RECTUM AND HAD A RECTO-URETHRAL FISTULA. OPEN LAPAROTOMY TECHNIQUES WERE UTILIZED TO PERFORM A DIVERTING COLOSTOMY TO REPAIR THE PATIENT'S RECTUM. THE PATIENT WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2013 AND IS REPORTED TO BE HEALING WELL. THE PATIENT'S FISTULA RESOLVED WITH A URETHRAL CATHETER AND THE COLOSTOMY WILL BE REVERSED IN 1 - 2 MONTHS. THE INITIAL REPORTER INDICATED THAT PER THE SURGEON THE ROOT CAUSE OF THE INJURY SUSTAINED BY THE PATIENT IS UNKNOWN, SINCE THE INJURY TO THE PATIENT WAS UNRECOGNIZED INTRA-OPERATIVELY DURING THE SURGICAL PROCEDURE. THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT AND MCS TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE AND A VISUAL INSPECTION OF THE CANNULA WAS PERFORMED. ARCING FROM THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WITH THE MCS TIP COVER ACCESSORY INSTALLED WAS NOT OBSERVED DURING THE SURGICAL PROCEDURE. THE MCS INSTRUMENT DID NOT MAKE CONTACT WITH ANY OTHER INSTRUMENT DURING THE SURGICAL PROCEDURE AND THERE IS NO VIDEO RECORDING OF THE PROCEDURE. AN EXCALIBUR PLUS 36 ELECTROSURGICAL UNIT (ESU) WAS USED DURING THE SURGICAL PROCEDURE. THE ESU SETTINGS WERE COAG 30 AND CUT 30.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE WEEK POST OP A DA VINCI S UROLOGICAL PROCEDURE PERFORMED ON (B)(6) 2013, IT WAS DISCOVERED THAT THE PATIENT HAD SUSTAINED A BOWEL INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242315 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179-10 0130128 782

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention DAV S SYS., MCS TIP CVR, INSTRMNTS, ACCESS AND ES