{ "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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GIVEN THIS RENT AND CONTINUED DIFFICULTY IN CLEARLY IDENTIFYING THE URETERS AS NECESSARY TO FREE THE OVARIES, THE PHYSICIAN WAS CONSULTED AND CAME TO THE OR AND ASSISTED IN COMPLETING THE BSO, LYSIS OF ADHESIONS AND URETEROLYSIS AND REPAIRED THE RENT IN THE SEROSA OF THE SIGMOID COLON." }, { "mdr_text_key": "18437632", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE INTRA-OPERATIVE INJURY SUSTAINED BY THE PATIENT HAS NOT BEEN DETERMINED. ISI HAS MADE SEVERAL ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE SITE'S RISK MANAGEMENT DEPARTMENT REGARDING THE REPORTED EVENT. AS OF THE DATE OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. 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 INJURY SUSTAINED BY THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI SURGICAL PROCEDURE, THE SEROSA OF THE PATIENT SIGMOID COLON WAS DAMAGED." }, { "mdr_text_key": "33113151", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON OCTOBER 17, 2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL INFORMATION FROM THE INITIAL REPORTER OF THIS COMPLAINT. ACCORDING TO THE INITIAL REPORTER THE PATIENT IS IN STABLE CONDITION. THE INITIAL REPORTER INDICATED THAT HOSPITAL'S INVESTIGATION DID NOT DETERMINE WHAT CAUSED THE INJURY TO THE PATIENT'S SIGMOID COLON AND THAT THE DEFECT WAS REPAIRED USING LAPAROSCOPIC TECHNIQUES. ACCORDING TO THE INITIAL REPORTER, DUE TO HIPAA REGULATIONS THE HOSPITAL IS UNABLE TO PROVIDE ISI WITH A COPY OF THE PATIENT'S OPERATIVE REPORT AND IT IS UNKNOWN IF THE SURGICAL PROCEDURE WAS RECORDED." } ], "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": "10/29/2014" } ] }