{ "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": "2955842-2016-00220", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20160401", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "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": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20160401", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "197178", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20160401", "brand_name": "DA VINCI XI 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": "IS4000 A70P4B", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250812", "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": "20160401", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Erythema", "Skin Discoloration", "Post Operative Wound Infection", "Erythema", "Skin Discoloration", "Post Operative Wound Infection" ] } ], "distributor_city": "", "date_report": "20160304", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5542560", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20160309", "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": "41721426", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE ALLEGED POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. ISI HAS REVIEWED THE SURGEON'S PROCEDURE HISTORY AND THE SYSTEM LOGS PERTAINING TO THE SURGICAL PROCEDURES LIKELY INVOLVED WITH THE REPORTED POST-OPERATIVE PORT SITE INFECTIONS. AGAIN, THE SPECIFIC PROCEDURE DATES INVOLVING THE POST-OPERATIVE PORT SITE INFECTIONS ARE UNKNOWN. ACCORDING TO THE SURGEON'S PROCEDURE HISTORY, HIS FIRST DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE WAS PERFORMED ON (B)(6) 2016. HE PERFORMED SUBSEQUENT DA VINCI-ASSISTED PROSTATECTOMY PROCEDURES ON (B)(6) 2016. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING ANY OF THE SURGICAL PROCEDURES. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER COMPLETION OF A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE, THE PATIENT REPORTEDLY DEVELOPED POST-OPERATIVE PORT SITE INFECTIONS THAT REQUIRED DEBRIDEMENT. HOWEVER, AT THIS TIME, THE CAUSE OF THE POST-OPERATIVE COMPLICATIONS IS UNKNOWN. THERE IS NO INDICATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED OR CAUSED/CONTRIBUTED TO THE PATIENT'S POST-OPERATIVE COMPLICATIONS. REFER TO MDRS WITH PATIENT IDENTIFIER 'S (B)(6) FOR INFORMATION REGARDING THE THREE OTHER REPORTED CASES INVOLVING POST-OPERATIVE PORT SITE INFECTIONS." }, { "mdr_text_key": "41721427", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE, THE SURGICAL STAFF NOTICED THAT THE PORT SITE INCISIONS WERE DISCOLORED. THE INCISION PORT SITES WERE DESCRIBED AS BEING WHITE WITH A DISCOLORED SURROUNDING AREA IN RED. THE PORT SITE INCISIONS REPORTEDLY DID NOT CLOSE POST-OPERATIVELY AFTER A FEW DAYS AND THE PORT SITES ALLEGEDLY BECAME INFECTED. ACCORDING TO THE INITIAL REPORTER, DEBRIDEMENT WAS PERFORMED TO HELP CLOSE EACH PORT SITE INCISION. THE INITIAL REPORTER ALSO INDICATED THAT THE POST-OPERATIVE PORT SITE INFECTIONS HAD OCCURRED IN 3 ADDITIONAL DA VINCI-ASSISTED PROSTATECTOMY PROCEDURES PERFORMED BY THE SAME SURGEON. THE INITIAL REPORTER INDICATED THAT 33 OTHER DA VINCI-ASSISTED SURGICAL PROCEDURES PERFORMED BY A DIFFERENT SURGEON DID NOT RESULT WITH POST-OPERATIVE PORT SITE INFECTIONS. BOTH SURGEONS WERE REPORTEDLY USING THE SAME GENERATOR SETTINGS. THE SITE PROVIDED 2 SEPARATE AND DIFFERENT PHOTOGRAPHIC IMAGES OF THE RELATED PORT SITE INFECTIONS. THE 2 IMAGES REVEAL VARIOUS PORT SITES WITH EVIDENCE OF POSSIBLE POST-OPERATIVE INFECTIONS AND AT VARIOUS STAGES OF HEALING. THE SITE INITIALLY DETERMINED THAT THE POST-OPERATIVE PORT SITE INFECTIONS MIGHT HAVE BEEN THE RESULT OF THE FOLLOWING: SURGICAL SITE INFECTIONS CAUSED BY CONTAMINATION, THE USE OF DERMABOND, OR ELECTRIC AFFECTION TO THE PORTS BY ELECTRIC CAUTERY. ON (B)(6) 2016, AN INTUITIVE SURGICAL, INC. (ISI) REPRESENTATIVE OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENTS: THERE WERE NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS. IN ADDITION, THERE WERE NO REPORTS THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURES. THE INITIAL REPORTER WAS UNABLE TO PROVIDE THE SPECIFIC DATES EACH DA VINCI-ASSISTED PROSTATECTOMY WAS PERFORMED IN RELATION TO THE POST-OPERATIVE PORT SITE INFECTIONS. ON (B)(6) 2016, THE ISI REPRESENTATIVE PROVIDED THE FOLLOWING INFORMATION: THE SURGEON HAS PERFORMED SUBSEQUENT DA VINCI-ASSISTED PROSTATECTOMY PROCEDURES WITH NO REPORTED RECURRENCES OF POST-OPERATIVE PORT SITE INFECTIONS. SO FAR, THE SITE HAS IMPLEMENTED THE FOLLOWING CHANGES: CHANGED THE GENERATOR, DISCONTINUED THE USE OF DERMABOND FOR PORT SITE CLOSURES, AND STARTED THE USE OF SURGICAL GOWNS WITH MASKS AND DOUBLING THE MASKS. ACCORDING TO ISI CLINICAL SALES REPRESENTATIVE (CSR), THE SITE CONFIRMED THAT THERE WERE NO ISSUES WITH THE CAUTERY DEVICES, GENERATOR, OR GENERATOR SETTINGS USED BY THE SURGEON INVOLVED WITH THE POST-OPERATIVE PORT SITE INFECTIONS. THERE IS SPECULATION FROM THE SITE THAT THE LIKELY CAUSE OF THE POST-OPERATIVE PORT SITE INFECTIONS IS THE USE OF POST-OPERATIVE MEDICATION WHICH IS BELIEVED TO BE THE DERMABOND OR AN UNSPECIFIED MEDICATION INTERACTING WITH DERMABOND. AS OF THE DATE OF THIS REPORT, THE SITE IS STILL PERFORMING AN INVESTIGATION TO DETERMINE THE POSSIBLE ROOT CAUSE OF THE POST-OPERATIVE PORT SITE INFECTIONS." }, { "mdr_text_key": "63103665", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE INITIAL MDR WAS SUBMITTED ON 04/01/2016 WITH AN INCORRECT DATE RECEIVED BY MFR VALUE OF 03/09/2016. THIS FOLLOW-UP MDR IS BEING SUBMITTED WITH A CORRECTED VALUE OF 03/04/2016." } ], "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": "12/21/2016" } ] }