BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIP COVER ACCESSORY

    MDR report key: 6527364 · Received April 27, 2017

    Report

    Report Number
    2955842-2017-00255
    Event Type
    Injury
    Date Received
    April 27, 2017
    Date of Event
    June 8, 2016
    Report Date
    April 3, 2017
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE ALLEGED POST-OPERATIVE COMPLICATION EXPERIENCED BY THE PATIENT. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2016. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE DA VINCI SURGICAL PROCEDURE. THE SYSTEM LOGS REVEAL THAT THE MCS INSTRUMENT (PART 470179-13; LOT S11160105-0083) USED DURING THE SURGICAL PROCEDURE WAS USED IN SUBSEQUENT SURGERIES UNTIL ZERO LIVES REMAINED ON THE INSTRUMENT. THE LEGAL DOCUMENT PROVIDED BY THE PLAINTIFF'S ATTORNEY MENTIONS THE CLASS 2 RECALL OF THE 8 MM MCS INSTRUMENT FROM MAY 2013. IN REFERENCE TO THE URGENT MEDICAL DEVICE RECALL 2955842-05-16-2013-005, THE AFFECTED MCS INSTRUMENTS HAD PART 'S 420179-09, 420179-10, 400179-09, AND 400179-10. IN THIS CASE, THE MCS INSTRUMENT USED DURING THE SURGICAL PROCEDURE HAS A PART OF 470179-13. THEREFORE, IT IS UNLIKELY THAT THE MCS INSTRUMENT ISSUE NOTED WITHIN THE RECALL IS RELATED TO THE REPORTED EVENT. NO COMPLAINTS HAVE BEEN REPORTED BY THE SITE REGARDING THE MCS INSTRUMENT OR A MCS TIP COVER ACCESSORY USED DURING THE SURGICAL PROCEDURE. THE VERSION NUMBER OF THE MCS TIP COVER ACCESSORY USED DURING THE SURGICAL PROCEDURE IS UNKNOWN. THE INSTRUMENTS & ACCESSORIES USER MANUAL PROVIDES A NUMBER OF GENERAL PRECAUTIONS AND WARNINGS REGARDING THE USE OF THE MCS INSTRUMENT IN CONJUNCTION WITH A MCS TIP COVER ACCESSORY. THE INTENDED USE OF THE MCS TIP COVER ACCESSORY IS TO PROVIDE INSULATION OVER A SECTION OF THE ENDOWRIST MONOPOLAR CURVED SCISSORS INSTRUMENT SO THAT RF ENERGY IS ONLY AVAILABLE AT THE TIP. THE USER MANUAL STATES, WARNING: FAILURE TO FOLLOW THESE PRECAUTIONS WILL RESULT IN ELECTRICAL ARCS FROM THE WRIST AND ALTERNATE SITE BURNS. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MDR WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PLAINTIFF'S ATTORNEY CLAIMS THAT THE PATIENT SUSTAINED A THERMAL INJURY WHILE UNDERGOING A DA VINCI-ASSISTED SURGICAL PROCEDURE. HOWEVER, THE ROOT CAUSE OF THE ALLEGED OPERATIVE COMPLICATION IS UNKNOWN.

    Description of Event or Problem · 1

    AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI-ASSISTED HYSTERECTOMY AND BILATERAL SALPINGECTOMY ON (B)(6) 2016 FOR CERVICAL DYSPLASIA. ISI WAS PROVIDED WITH THE OPERATIVE REPORT FOR THE DA VINCI-ASSISTED SURGICAL PROCEDURE. THERE IS NO INDICATION WITHIN THE OPERATIVE REPORT THAT ANY INTRA-OPERATIVE COMPLICATIONS OR A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ACCORDING TO A LEGAL DOCUMENT PROVIDED BY THE PLAINTIFF'S ATTORNEY, THE PATIENT ALLEGEDLY EXPERIENCED POST-OPERATIVE URINARY INCONTINENCE AND WAS DIAGNOSED ON (B)(6) 2016 WITH A VESICOVAGINAL FISTULA. THE PLAINTIFF'S ATTORNEY CLAIMED THAT THE PATIENT'S BLADDER HAD A HOLE THAT CONNECTED TO HER VAGINA THROUGH WHICH ALL HER URINE WAS UNCONTROLLABLY FLOWING OUT. THE PLAINTIFF'S ATTORNEY ALSO CLAIMS THAT PHYSICIANS DETERMINED THE FISTULA TO BE A RESULT OF A THERMAL INJURY. FURTHERMORE, THE PLAINTIFF'S ATTORNEY NOTED, LATER IMAGING CONFIRMED THE CAUTERIZED, CLEARLY DEFINED EDGES OF THE HOLE CREATED BY THE UNINTENDED ELECTRICAL DISCHARGE OF YOUR PRODUCT. THE LEGAL DOCUMENT PROVIDED BY THE PLAINTIFF'S ATTORNEY MENTIONS THE POTENTIAL FOR A MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT TO DEVELOP VERY SMALL CRACKS NEAR THE DISTAL END WHICH MAY CREATE A PATHWAY FOR ELECTROSURGICAL ENERGY TO LEAK TO TISSUE AND POTENTIALLY CAUSE THERMAL INJURY. THE PLAINTIFF'S ATTORNEY NOTED THAT A MCS INSTRUMENT WAS USED DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE. ON (B)(6) 2016, THE PATIENT UNDERWENT VAGINAL FISTULA REPAIR, CYSTOSCOPY, AND SUPRAPUBIC CATHETER PLACEMENT. POST-OPERATIVELY, THE PATIENT REQUIRED A FOLEY CATHETER AND A SUPRAPUBIC CATHETER. SHE ALSO ALLEGEDLY EXPERIENCED VIOLENT, SHARP ABDOMINAL PAIN AND INCAPACITATING CRAMPS AND SPASMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307654 TIP COVER ACCESSORY ENDOSCOPIC INSTRUMENT ACCESSORY NAY INTUITIVE SURGICAL,INC. 400180

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R