{ "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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(ISI) SPOKE WITH THE SITE'S DIRECTOR OF RISK MANAGEMENT. SHE INDICATED THAT THE SITE DOES NOT HAVE ANY REPORTS OF ANY ISSUES OR MALFUNCTIONS OF THE DA VINCI SURGICAL SYSTEM RELATED TO THE DA VINCI HYSTERECTOMY SURGERY THAT WAS PERFORMED ON (B)(6) 2011. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS STILL BEING REPORTED BASED ON THE INITIAL COMPLAINT: THE PATIENT ALLEGEDLY EXPERIENCED POST SURGICAL COMPLICATIONS AFTER UNDERGOING THE DA VINCI SURGICAL PROCEDURE." }, { "mdr_text_key": "18807296", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY WITH DRAINAGE OF TWO RIGHT OVARIAN CYSTS AND CYSTOSCOPY PROCEDURE ON (B)(6) 2011 FOR PELVIC PAIN AND MENOMETRORRHAGIA. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. A PATHOLOGY REPORT OF THE REMOVED SPECIMENS WAS ALSO PROVIDED. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. WHEN THE PATIENT WAS PRESENTED WITH THE OPTION OF A LAPAROSCOPIC EXAM AND ABLATION SHE ADAMANTLY DESIRED A HYSTERECTOMY. THIS WAS A STANDARD SURGERY WITH THE EXCEPTION OF DRAINAGE OF TWO CYSTS ON THE PATIENT'S RIGHT OVARY. AS THE LEFT OVARY HAD BEEN REMOVED DURING A PRIOR SURGERY, THE REMAINING PORTION OF THE LEFT TUBE WAS SURGICALLY REMOVED DURING THE HYSTERECTOMY PROCEDURE. CYSTOSCOPY WAS PERFORMED, WITH INDIGO CARMINE EFFLUXING FROM BOTH URETERAL ORIFICES. THE PATIENT WAS TAKEN TO THE PACU IN STABLE CONDITION. ON (B)(6) 2011, THE PATIENT PRESENTED WITH POSTOPERATIVE BLEEDING AND WAS DIAGNOSED WITH VAGINAL DEHISCENCE. A 1.5-2CM OPENING AT THE VAGINAL CUFF WAS NOTED AND REPAIRED. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER SURGICAL NOTE OF (B)(6) 2011." }, { "mdr_text_key": "19279293", "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. THE MEDICAL RECORDS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. 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 SURGICAL 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": "05/20/2014" } ] }