{ "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) HAS NOT DETERMINED THE ROOT CAUSE FOR THE OPERATIVE COMPLICATION(S) EXPERIENCED BY THE PATIENT. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S ATTORNEY ALLEGED THAT THE PATIENT SUSTAINED INJURIES DURING DA VINCI SURGICAL PROCEDURE AND REQUIRED SURGICAL INTERVENTION. THIS REPORT DOES NOT ADMIT THAT THE REPORT OR INFORMATION SUBMITTED UNDER THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, INTUITIVE SURGICAL OR INTUITIVE SURGICAL EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT." }, { "mdr_text_key": "20695482", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI HYSTERECTOMY ON (B)(6) 2012. THE LEGAL DOCUMENT ALLEGES THAT DURING THE SURGICAL PROCEDURE HER URETER, VAGINA BLADDER, AND OTHER ORGANS NOT ASSOCIATED WITH THE PROCEDURE WERE NEGLIGENTLY INJURED, AND THESE INJURIES RESULTED IN THE NECESSITY OF CONTINUED FOLLOW-UP CARE, SURGICAL INTERVENTION, AND EMBARRASSING SIDE-EFFECTS. IN ADDITION, THE LEGAL DOCUMENT CLAIMS THAT THE PATIENT HAS UNDERGONE SEVERE PHYSICAL PAIN AND MENTAL ANGUISH, SUFFERED PERMANENT DEBILITATING INJURIES, INCURRED SUBSTANTIAL HOSPITAL AND MEDICAL BILLS AND RELATED COSTS, LOST WAGES, AND WILL CONTINUE TO SUFFER SUCH DAMAGES IN THE FUTURE." } ], "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": "" } ] }