BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    MDR report key: 3206027 · Received July 3, 2013

    Report

    Report Number
    2955842-2013-02435
    Event Type
    Injury
    Date Received
    July 3, 2013
    Report Date
    June 5, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON JULY 10TH, 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL INFORMATION FROM THE HOSPITAL'S CORPORATE COMPLIANCE OFFICE. THE COMPLIANCE OFFICER INDICATED THAT THE PATIENT UNDERWENT DA VINCI HYSTERECTOMY WITH LEFT SALPINGO OOPHORECTOMY AND LYSIS OF ADHESION PROCEDURE ON (B)(6) 2013. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS NOTED TO HAVE BEEN EXPERIENCED BY THE PATIENT. A PK (GYRUS) ELECTROSURGICAL UNIT WAS USED DURING THE SURGICAL PROCEDURE AND STANDARD SETTINGS WERE USED. THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT, MCS TIP COVER ACCESSORY AND CANNULA WERE INSPECTED BY THE SURGICAL TECHNICIAN PRIOR TO USE. IT IS BELIEVED BY THE COMPLIANCE OFFICER THAT THE MCS INSTRUMENT LIKELY MADE CONTACT WITH A ROBOTIC PK COAGULATOR INSTRUMENT THAT WAS ALSO BEING USED DURING THE SURGICAL PROCEDURE. THERE IS NO VIDEO RECORDING AVAILABLE OF THE SURGICAL PROCEDURE. THE CORPORATE COMPLIANCE OFFICER INDICATED THAT TWO DAYS POST-OP THE PATIENT UNDERWENT A LAPAROSCOPIC SURGICAL PROCEDURE IN THE HOSPITAL'S EMERGENCY ROOM TO HAVE HER BOWEL REPAIRED. THE AFFECTED AREA WAS OVER OVERSEWN. THE PATIENT'S MEDICAL CARE ALSO INCLUDED TOTAL PARENTERAL NUTRITION, BROAD SPECTRUM ANTIBIOTICS AND NASOGASTRIC SUCTION. THE PATIENT SUBSEQUENTLY DEVELOPED A RECTOVAGINAL FISTULA AT A TERTIARY CENTER AND UNDERWENT A SURGICAL PROCEDURE TO REPAIR THE AFFECTED AREA. THE PATIENT IS NOW DOING WELL.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2013, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE. THE SURGEON INDICATED THAT THE PATIENT UNDERWENT A DA VINCI S GYNECOLOGICAL PROCEDURE APPROXIMATELY 1 YEAR AGO AND THAT 3 DAYS POST OP, THE PATIENT WAS DIAGNOSED WITH PERITONITIS AND IT WAS DISCOVERED THAT THE PATIENT'S ABDOMINAL CAVITY CONTAINED FECAL MATTER. THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO HAVE HER BELLY FLUSHED. THE SURGEON INDICATED THAT ARCING DURING THE SURGICAL PROCEDURE WAS NOT OBSERVED; HOWEVER, IT IS HER BELIEF THAT THE INJURY SUSTAINED BY THE PATIENT COULD HAVE OCCURRED DUE TO ARCING FROM THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT THAT WAS USED DURING THE SURGICAL PROCEDURE. THE SURGEON INDICATED THAT THE PATIENT IS NOW DOING FINE. THIS COMPLAINT IS BEING REPORTED DUE TO POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT AS A RESULT OF A BOWEL INJURY THAT OCCURRED DURING A DA VINCI SURGICAL PROCEDURE. BASED ON THE INFORMATION PROVIDED, ISI IS UNABLE TO DETERMINE THE ROOT CAUSE OF THE INJURY SUSTAINED BY THE PATIENT. PER THE INFORMATION PROVIDED BY THE INITIAL REPORTER, THE MONOPOLAR CURVED SCISSORS INSTRUMENT WAS DISCARDED. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A DA VINCI S GYNECOLOGICAL PROCEDURE APPROXIMATELY ONE YEAR AGO, SUSTAINED A SMALL BURN ON THE BOWEL. IT IS THE SURGEON'S BELIEF THAT THE BURN INJURY SUSTAINED BY THE PATIENT MAY HAVE BEEN CAUSED BY ARCING FROM THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT USED DURING THE SURGICAL PROCEDURE. THE MCS INSTRUMENT WAS DISCARDED. NO OTHER DETAILS REGARDING THE REPORTED EVENT WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306000 MONOPOLAR CURVED SCISSORS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420179

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other| R DAV S SURG SYS, INSTRUMENTS, ACCESSORIES & ESU.