{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. 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THE PATIENT REPORTEDLY DEVELOPED STRESS INCONTINENCE, NOCTURIA, URINARY FREQUENCY, ERECTILE DYSFUNCTION, AND POSSIBLY URETHRAL SPHINCTER FOLLOWING THE DA VINCI SURGERY. THE PATIENT'S MEDICAL RECORDS DATED (B)(6) 2012, RELATED TO THE PATIENT'S PRE-OPERATIVE CARE WERE PROVIDED. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT WAS SEEN BY A MEDICAL ONCOLOGIST IN (B)(6) 2012. DUE TO A RECENT RISE IN PROSTATE-SPECIFIC ANTIGEN (PSA) LEVELS, THE ONCOLOGIST DISCUSSED CLOSE VIGILANT OBSERVATION VS. DEFINITIVE TREATMENTS SUCH AS SURGICAL OPTION OR RADIATION THERAPY. HE WAS INFORMED OF THE POTENTIAL MORBIDITIES ASSOCIATED WITH DEFINITIVE TREATMENT AND MOST NOTABLY WILL AFFECT HIS ERECTILE FUNCTION. ACCORDING TO THE PATIENT'S DISCHARGE SUMMARY DOCUMENT, THE PATIENT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2012, WITH NO ISSUES AND COMPLICATIONS AND WAS DISCHARGED ON (B)(6) 2012. THE DA VINCI OPERATIVE REPORT WAS NOT PROVIDED. ADDITIONAL MEDICAL RECORDS DATED (B)(6) 2013, RELATED TO THE PATIENT'S POST-OPERATIVE CARE WERE PROVIDED. THE MEDICAL RECORD NOTED THAT THE PATIENT DEVELOPED STRESS INCONTINENCE, NOCTURIA, URINARY FREQUENCY, ERECTILE DYSFUNCTION, AND POSSIBLE URETHRAL SPHINCTER INSUFFICIENCY SECONDARY TO THE PROSTATECTOMY SURGERY. THE DOCTOR'S LETTER SUMMARY ALSO NOTED THAT THE PATIENT'S PSA LEVELS WERE BARELY DETECTABLE INDICATING THERE WAS NO EVIDENCE OF PROSTATE CANCER. THE MEDICAL RECORDS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY." }, { "mdr_text_key": "11223153", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE POST-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE 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. ON (B)(4) 2013, ISI SPOKE WITH THE SITE'S RISK MANAGEMENT GROUP. THE RISK MANAGEMENT COORDINATOR STATED SHE DOES NOT HAVE ANY REPORTS RELATED TO THE REPORTED EVENT BUT WILL CONTACT ISI IF SHE HAS ANY ADDITIONAL INFORMATION. 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 SI SURGICAL PROSTATECTOMY PROCEDURE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }