{ "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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IN EACH PROCEDURE, THE ERRORS COULD NOT BE BYPASSED CAUSING THE PATIENT NOT TO GET THE ENTIRE LASER TREATMENT PLANNED. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION IS UNKNOWN. THIS REPORT IS FOR THE FIRST CONSOLE." }, { "mdr_text_key": "308531731", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS FOR THE SAME EVENT SUBMITTED BY THE USER FACILITY TO FDA REPORT NUMBER: 2300460000-2022-8009." }, { "mdr_text_key": "335532150", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPON FURTHER REVIEW OF THE INFORMATION AVAILABLE, IT WAS INDICATED BY THE USER FACILITY REPORT THAT THE SURGITOUCH WAS UTILIZED IN CO2 (FRACTIONAL RESURFACING LASER) PROCEDURE WHICH IS NOT A SURGICAL PROCEDURE AS INITIALLY SUSPECTED. THE MANUFACTURER HAS REVIEWED ALL INFORMATION AND DETERMINED THIS EVENT NO LONGER MEETS REPORTING CRITERIA FOR THE DEVICE IN QUESTION. THIS REPORT IS FOR THE SAME EVENT SUBMITTED BY THE USER FACILITY TO FDA REPORT NUMBER: (B)(4). MANUFACTURER E-MAIL: (B)(4)." }, { "mdr_text_key": "335532151", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED VIA USER FACILITY REPORT THAT UNSPECIFIED ERRORS WERE ENCOUNTERED BY TWO LASER CONSOLES DURING PROCEDURES. IN EACH PROCEDURE, THE ERRORS COULD NOT BE BYPASSED CAUSING THE PATIENT NOT TO GET THE ENTIRE LASER TREATMENT PLANNED. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION IS UNKNOWN. 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