{ "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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(B)(6) REPORTED THAT ON (B)(6) 2022, A GASTROSCOPY WAS PERFORMED FOR DYSPHAGIA. THIS EVENT REVEALED A BOLUS OCCLUSION IN THE LOWER ESOPHAGUS WITH NECROSIS OF THE WALL TO INDICATE AN ESOPHAGEAL PERFORATION. THE PATIENT WAS TREATED VIA RE-LAPAROSCOPY, ESOPHAGEAL SUTURE, ESOSPONGE, AND SEVERAL VAC CHANGES. VAC THERAPY WAS COMPLETED ON (B)(6) 2022 ON (B)(6) 2022, AN X-RAY SWALLOW SHOWED TIGHTNESS AND AFTER A SLOW BUILD-UP OF FOOD, THE PATIENT WAS DISCHARGED ON (B)(6) 2022. AT HOME THE PATIENT WAS LISTLESS AND WAS RE-ADMITTED AS INPATIENT FROM (B)(6) 2022 THRU (B)(6) 2022 WHEN SHE WAS DISCHARGED. AFTER THIS PERIOD, PATIENT DID WELL WITH NO WEIGHT LOSS AND NO DYSPHAGIA. IT WAS REPORTED THAT CAUSALITY TO THE SENHANCE SURGICAL SYSTEM WAS CERTAIN. THIS EVENT DID NOT OCCUR WITHIN THE UNITED STATES. THE EVENT OCCURRED IN (B)(6). ADDITIONALLY, THIS EVENT OCCURRED ON (B)(6) 2022, AND ASENSUS SURGICAL WAS INTERNALLY MADE AWARE ON 02-DECEMBER- 2022." }, { "mdr_text_key": "338797770", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE COMPLAINT DETAILS, THERE WAS A REPORT OF AN ADVERSE EVENT TO A PATIENT. THIS EVENT DID NOT OCCUR WITHIN THE U.S. THIS EVENT OCCURRED AT (B)(6). THE EVENT OCCURRED ON (B)(6) 2022, AND ASENSUS SURGICAL WAS INTERNALLY MADE AWARE ON 02-DEC-2022. ACCORDING TO THE INVESTIGATION, FURTHER RESPONSES FROM THE SURGEON CONFIRMED THAT THE PROBLEM WAS ASSOCIATED WITH THE MEDICAL HISTORY OF THE PATIENT AND NOT RELATED THE SENHANCE SURGICAL SYSTEM. NO CAUSALITY WITH THE SENHANCE SURGICAL SYSTEM WAS IDENTIFIED. FURTHERMORE, NO MALFUNCTION OF THE SENHANCE SYSTEM WAS REPORTED. NO FAILURES WERE IDENTIFIED. THE RISK POSED BY THIS EVENT WAS EVALUATED THOUGH HHE-001-00034 AND A CORRECTIVE ACTION PREVENTATIVE ACTION PLAN (CAPA-000048) HAS BEEN OPENED TO MANAGE THE UNSUITABLE TIMELINESS OF THE RECEIPT AND MANAGEMENT OF THIS REPORTED EVENT." }, { "mdr_text_key": "323744578", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE COMPLAINANT, DR. (B)(6), REPORTED THAT ON (B)(6) 2022, A GASTROSCOPY WAS PERFORMED FOR DYSPHAGIA. THIS EVENT REVEALED A BOLUS OCCLUSION IN THE LOWER ESOPHAGUS WITH NECROSIS OF THE WALL TO INDICATE AN ESOPHAGEAL PERFORATION. THE PATIENT WAS TREATED VIA RE-LAPAROSCOPY, ESOPHAGEAL SUTURE, ESOSPONGE, AND SEVERAL VAC CHANGES. VAC THERAPY WAS COMPLETED ON (B)(6) 2022. ON (B)(6) 2022, AN X-RAY SWALLOW SHOWED TIGHTNESS AND AFTER A SLOW BUILD-UP OF FOOD, THE PATIENT WAS DISCHARGED ON (B)(6) 2022. AT HOME THE PATIENT WAS LISTLESS AND WAS RE-ADMITTED AS INPATIENT FROM (B)(6) 2022 THRU (B)(6) 2022 WHEN SHE WAS DISCHARGED. AFTER THIS PERIOD, PATIENT DID WELL WITH NO WEIGHT LOSS AND NO DYSPHAGIA. IT WAS REPORTED THAT CAUSALITY TO THE SENHANCE SURGICAL SYSTEM WAS CERTAIN. THIS EVENT DID NOT OCCUR WITHIN THE UNITED STATES. THE EVENT OCCURRED IN (B)(6). ADDITIONALLY, THIS EVENT OCCURRED ON (B)(6) 2022, AND ASENSUS SURGICAL WAS INTERNALLY MADE AWARE ON 02-DECEMBER-2022." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "VIALE DELL'INNOVAZIONE 3", "distributor_zip_code": "", "manufacturer_contact_postal_code": "277037035", "manufacturer_contact_exchange": "919", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "10/13/2023" } ] }