{ "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) IS NOT EXPECTING ANY PRODUCT TO BE RETURNED AS PART OF THIS COMPLAINT, AS THERE WAS NO ALLEGATION OF A PRODUCT ISSUE. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. A LOG REVIEW CONFIRMED THE PROCEDURE DATE OF (B)(6) 2022 ON SYSTEM (B)(4). NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. BASED ON THE INFORMATION AVAILABLE AT THIS TIME, THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER CONVERTED TO OPEN SURGERY AFTER THE START OF A DA VINCI PROCEDURE. THERE WAS NO KNOWN ISSUE WITH THE DA VINCI SYSTEM THAT CONTRIBUTED TO THE DECISION TO CONVERT THE PROCEDURE. THE PATIENT WAS SAID TO HAVE TOLERATED THE PROCEDURE WITH NO REPORTED ISSUES." }, { "mdr_text_key": "298115198", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, THE SURGEON HAD TO CONVERT TO OPEN SURGERY. 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