{ "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. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "HOSPITAL", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "2955842-2013-05238", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20131118", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130321", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Other" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20131118", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "595520", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131118", "brand_name": "DA VINCI SURGICAL SYSTEM", "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL,INC.", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS3000 A6.0P8", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Device Alarm System", "Device Displays Incorrect Message" ], "reporter_state_code": "OK", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250824", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20131118", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Tissue Damage", "Injury" ] } ], "distributor_city": "", "date_report": "20130918", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3473414", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20141126", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "11337761", "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 FOR THE INTRA-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. ON (B)(4) 2013, ISI CONTACTED THE RISK MANAGER FROM THE SITE. THE RISK MANAGER WAS UNWILLING TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. 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. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2013. THE SYSTEM LOGS REVEAL THAT A RECOVERABLE ERROR 23002 POINTING TO AXIS 8 ON THE RIGHT MASTER TOOL MANIPULATOR (MTMR) OCCURRED FIVE TIMES DURING THE SURGICAL PROCEDURE. AN ERROR 23002 INDICATES THE ENCODER THINKS THE JOINT WENT BEYOND THE MECHANICAL LIMIT. A BAD HOME POSITION (DUE TO A FAULTY OR SLIPPED POT), A BAD ENCODER OR BROKEN HARD STOP MAY BE THE CAUSE. THE MASTER TOOL MANIPULATOR REFERS TO THE MASTER CONTROLLERS WHICH PROVIDE THE MEANS FOR THE SURGEON TO CONTROL THE INSTRUMENTS AND ENDOSCOPE INSIDE THE PATIENT FROM THE SURGEON'S SIDE CONSOLE. ONE MTM IS ASSIGNED TO THE SURGEON'S LEFT HAND (MTML) AND ONE TO HIS RIGHT (MTMR). BASED ON THE SYSTEM LOGS, THE SURGICAL STAFF WAS ABLE TO OVERRIDE THE ERROR 23002 WITHIN A MINUTE EACH TIME THE ERROR OCCURRED. IN ADDITION, THE SITE ALSO ENCOUNTERED AN ERROR 22005 MESSAGE THREE TIMES DURING THE PROCEDURE POINTING TO MTMR AXIS 2 AND 6. IN ONE INSTANCE, THE SURGICAL STAFF ALSO ENCOUNTERED AN ERROR 31009 MESSAGE. AN ERROR 31009 SIGNIFIES THAT A TOOL WAS FULLY DETECTED, AND THEN ONE OR MORE (BUT NOT ALL) OF THE TOOL SENSORS WERE NOT DETECTED FOR 3 SECONDS. ON (B)(4) 2013, AN ISI FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE RESOLVED THE ERROR 23002 ISSUE BY REPLACING THE RIGHT MTM GIMBAL. THE FSE ALSO TESTED THE SYSTEM TO MANUFACTURER SPECIFICATIONS. THE GIMBAL WAS RETURNED TO ISI AND EVALUATED BY FAILURE ANALYSIS (FA). NO ISSUES WERE FOUND WITH A VISUAL INSPECTION OF THE GIMBAL. THE GIMBAL WAS INSTALLED ON A TEST MTM/MINI-CONSOLE. A FULL RECALIBRATION WAS PERFORMED FIRST SINCE THE GIMBAL WAS FROM ANOTHER MTM. FA WAS ABLE TO DO A FULL RECALIBRATION WITH NO ISSUES. FA BACKDROVE EACH AXIS INCLUDING AXIS 8 (GRIPS) AND NO ERRORS WERE TRIPPED. FA ALSO PERFORMED A SINE CYCLE FOR 1 HOUR AND NO ERRORS WERE TRIPPED. FA WAS UNABLE TO REPLICATE THE CUSTOMER REPORTED ISSUE OF AN ERROR 23002. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE LEGAL DOCUMENT ALLEGES THAT THE PATIENT WAS FOUND TO HAVE A TEAR TO THE RECTUM WHILE UNDERGOING A DA VINCI PROSTATECTOMY PROCEDURE. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S INJURY IS UNKNOWN." }, { "mdr_text_key": "4029205", "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 PROSTATECTOMY ON (B)(6) 2013. THE LEGAL DOCUMENT ALLEGES THAT THE PATIENT WAS GRAVELY INJURED AS A RESULT OF THE MALFUNCTIONING ROBOTIC DEVICE. ACCORDING TO THE LEGAL DOCUMENT, THE SURGEON FOUND A SMALL TEAR ON THE PATIENT'S RECTUM DURING DISSECTION AND AFTER THE PROSTATE HAD BEEN COMPLETELY FREED. THE LEGAL DOCUMENT ALSO INDICATES THAT, DURING THE ANASTOMOSIS, THERE WERE AT LEAST 10 EPISODES OF ALARMS THAT WENT OFF, SECONDARY TO THE RIGHT HAND OF THE PROSTATE. THIS, ON TWO SEPARATE OCCASIONS, BROKE THE SUTURE AND ON EVERY OTHER SITUATION, CASED THE 1 ARM TO DROP THE NEEDLE." }, { "mdr_text_key": "33013638", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT AND OTHER MEDICAL RECORDS, AND LEGAL RECORDS. PER THE OPERATIVE REPORT, THE PATIENT WAS FOUND TO HAVE NUMEROUS ADHESIONS. DISSECTION WAS TAKEN ALL THE WAY BACK, FREEING THE PROSTATE. A SMALL TEAR IN THE RECTUM WAS NOTED. DURING ANASTOMOSIS, AT LEAST 10 EPISODES OF ALARMS WENT OFF SECONDARY TO THE RIGHT HAND OF THE PROSTATE. THE SURGEON NOTED THAT ON 2 OCCASIONS, A SUTURE BROKE AND ON EVERY OTHER SITUATION ARM 1 DROPPED THE NEEDLE. THE SURGEON NOTED, WE CALLED THE COMPANY AND ASKED THEM WHAT WAS GOING ON, IT CONTINUED TO DO THIS AND THEY SAID THAT [THEY] WOULD HAVE TO SEND THE TECHNICIAN OUT TO FIX IT. THE SURGEON GOT GOOD CLOSURE AT THAT POINT AND AN OPENING IN THE BLADDER WAS IDENTIFIED. THE BLADDER WAS CLOSED AT THE BLADDER NECK WITH A V-LOCK STITCH AND THE ANASTOMOSIS WAS COMPLETED. MINIMAL LEAKAGE WAS SEEN ON IRRIGATING THE BLADDER. A JP WAS PLACED NEAR THE ANASTOMOSIS AND THE BLADDER WAS ENCLOSED. ON (B)(6) 2013, THE PATIENT UNDERWENT CLOSURE OF A URINE LEAK. AN OPENING IN THE BLADDER NECK ON THE RIGHT SIDE WHERE THE PREVIOUS V-LOC SUTURE HAD BEEN PLACED WAS IDENTIFIED. THE V-LOC SUTURE HAD PULLED FREE. BILATERAL NEPHROSTOMIES WERE PLACED. ON (B)(6) 2013, A CT-SCAN OF THE ABDOMEN AND PELVIS REVEALED SOME EDEMA IN THE ANTERIOR PELVIC WALL, AIR, AND FLUID IN THIS STRUCTURE. THE SURGEON NOTED THAT DISTENDED LOOPS OF SMALL BOWEL THROUGHOUT THE ABDOMEN COULD REPRESENT ILEUS. THE SURGEON ALSO NOTED INTERVAL DEVELOPMENT OF BILATERAL MILD HYDRONEPHROSIS AND HYDROURETER. ON (B)(6) 2013, THE PATIENT HAD INCREASED COMPLAINTS OF NAUSEA, VOMITING, AND ABDOMINAL PAIN. A CT-SCAN REVEALED A VESICULAR RECTAL FISTULA WITH SOME COMMUNICATION WITH THE PELVIS ITSELF ALONG WITH A LARGE FISTULA IN THE ANTERIOR RECTAL WALL. THE MEDICAL IMPRESSION WAS A URINARY LEAK STATUS POST BILATERAL NEPHROSTOMIES; LEUKOCYTOSIS; ACUTE KIDNEY INJURY; AND DIVERTICULOSIS. FROM (B)(6) 2013 THROUGH (B)(6) 2014, THE PATIENT HAD MULTIPLE HOSPITALIZATIONS AND VISITS TO A REHABILITATION CENTER. DURING THAT TIME, THE PATIENT RECEIVED MEDICAL TREATMENT FOR NAUSEA, VOMITING, ABDOMINAL DISCOMFORT, PELVIC PAIN, ILEUS, UTI, PELVIC ABSCESS, RECTOVESICAL FISTULA, WOUND CARE, HYPOGLYCEMIA, HYDRONEPHROSIS, HEMATURIA, BLADDER/URETHRA STRICTURE, A SEIZURE, AND SEPSIS. THE PATIENT ALSO UNDERWENT SEVERAL RIGHT AND LEFT ANTEGRADE NEPHROSTOGRAM WITH NEPHROSTOMY TUBE EXCHANGES DURING THAT TIME. BASED ON THE ADDITIONAL INFORMATION PROVIDED, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: THE PATIENT WAS FOUND TO HAVE A TEAR TO THE RECTUM WHILE UNDERGOING A DA VINCI PROSTATECTOMY PROCEDURE. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S INJURY IS UNKNOWN." } ], "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": "12/24/2014" } ] }