BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 3347833 · Received September 13, 2013

    Report

    Report Number
    2955842-2013-03546
    Event Type
    Injury
    Date Received
    September 13, 2013
    Date of Event
    April 16, 2010
    Report Date
    August 16, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. THE OPERATIVE REPORTS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION FROM THE RISK MANAGEMENT GROUP AT THE SITE; HOWEVER, AS OF THE DATE OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE OF (B)(6) 2010 FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATED TO THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI S SURGICAL HYSTERECTOMY PROCEDURE.

    Description of Event or Problem · 1

    AS PART OF A LEGAL MEDIATION EFFORT ON (B)(4) 2013 INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION, INCLUDING MEDICAL RECORDS, OF A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE ON (B)(6) 2010. ON (B)(6) 2010, APPROXIMATELY 1 WEEK BEFORE THE HYSTERECTOMY PROCEDURE, THE PATIENT UNDERWENT A LOOP ELECTROSURGICAL EXCISION PROCEDURE (LEEP) AND ENDOCERVICAL CURETTAGE TO EVALUATE A HIGH-GRADE DYSPLASIA WITH FINDINGS OF SMALL FOCUS OF MICROINVASIVE SQUAMOUS CELL CARCINOMA OF THE CERVIX. ON (B)(6) 2010, THE PATIENT UNDERWENT THE DA VINCI SI HYSTERECTOMY WITH BILATERAL SALPINGO OOPHORECTOMY. ACCORDING TO THE OPERATIVE REPORT, THE NEOVASCULARIZATION AND HYPERTROPHY OF SMALL VESSELS WERE NOTED WITH INCREASED OOZING OF BLOOD, WHICH WAS CONTROLLED WITH CAUTERY AND CLOSURE OF THE VAGINAL CUFF. THE VAGINAL CUFF WAS CLOSED BY TAKING GENEROUS BITES BACK FROM THE DIVIDED EDGES OF THE VAGINA AS THE PATIENT WAS AT INCREASED RISK OF POOR WOUND HEALING AND SEROMA FORMATION, AS WELL AS POSTOPERATIVE HEMATOMA FORMATION. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION; NO COMPLICATIONS WERE NOTED. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. THE OPERATIVE REPORTS DID NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. ON (B)(6) 2010, THE PATIENT HAD COMPLAINTS OF VAGINAL BLEEDING OR BLOOD IN HER URINE. THE DOCTOR DISCUSSED THE POSSIBLE DIAGNOSES, INCLUDING CUFF CELLULITIS WITH A HEMATOMA OR SEROMA THAT MAY BE INFECTED, PRESCRIBED ANTIBIOTICS, AND ORDERED A CT SCAN. THE MEDICAL RECORD INDICATES THAT THIS WAS NOT UNEXPECTED, SINCE THE PATIENT HAD A SURGICAL PROCEDURE AFTER A LEEP. ON (B)(6) 2010 , THE PATIENT WAS HOSPITALIZED FOR THE MANAGEMENT OF POSTOPERATIVE ILEUS,AND POST -OPERATIVE SEROMA/HEMATOMA WITH ELEVATED WHITE BLOOD CELLS. ON (B)(6) 2010, THE PATIENT'S FOLLOW-UP CT SCAN WAS NOTED TO BE CONSISTENT WITH NORMAL FINDINGS. THE PATIENT'S CURRENT CONDITION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460956 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R DA VINCI S SYSTEM INSTRUMENTS AND ACCESSORIES