{ "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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UPON FURTHER INSPECTION, THERE APPEARED TO BE NOTCHES/GROOVES AROUND THE CENTER INSET CIRCLE THAT FITS ONTO THE ROBOT ARM. PHOTOS PROVIDED PERMITTED TO CONFIRM THE EVENT. THE MOST PROBABLE ROOT CAUSE OF THE DAMAGE OF THE INSTRUMENT HOLDER IS A SHOCK CAUSED BY A FALL OF THE INSTRUMENT OR BY A SHOCK WITH ANOTHER INSTRUMENT. THIS CANNOT BE CONFIRMED. CORRECTED DATA: B4: DATE OF THIS REPORT. G3: DATE RECEIVED BY MANUFACTURER. H2: IF FOLLOW-UP, WHAT TYPE. H3: DEVICE EVALUATED BY MANUFACTURER. H6: ADVERSE EVENT PROBLEM. H10: ADDITIONAL NARRATIVES/DATA. H3 OTHER TEXT: DEVICE WAS NOT RETURNED TO MANUFACTURER." }, { "mdr_text_key": "324263839", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "DURING SURGERY, BUT PRIOR TO FIRST INCISION, THE INSTRUMENT HOLDER (B)(6) COULD NOT BE PLACED ONTO THE END OF THE ROBOT ARM BY THE SURGEON. UPON FURTHER INSPECTION, THERE APPEARED TO BE NOTCHES/GROOVES AROUND THE CENTER INSET CIRCLE THAT FITS ONTO THE ROBOT ARM. THE INSTRUMENT HOLDER HAD TO BE FILED DOWN AROUND THIS CIRCLE INSET IN ORDER TO GET THE INSTRUMENT HOLDER TO SIT FLUSH ONTO THE ROBOT ARM. IT WAS DETERMINED THAT THE ROBOT ARM HAD NO ISSUE AS THE POINTER PROBE AND LASER ATTACHMENTS SAT FLUSH WITH NO FORCE NEEDED. THE PROCESS OF GETTING THE INSTRUMENT HOLDER ATTACHED TO THE ROBOT ARM DELAYED SURGERY BY 30-45 MINUTES WHILE THE PATIENT WAS UNDER ANESTHESIA." }, { "mdr_text_key": "206493116", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "UDI# : (B)(4). THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED." }, { "mdr_text_key": "206493117", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "DURING SURGERY, BUT PRIOR TO FIRST INCISION, THE INSTRUMENT HOLDER (MT-02-158 S18108) COULD NOT BE PLACED ONTO THE END OF THE ROBOT ARM BY THE SURGEON.UPON FURTHER INSPECTION, THERE APPEARED TO BE NOTCHES/GROOVES AROUND THE CENTER INSET CIRCLE THAT FITS ONTO THE ROBOT ARM. THE INSTRUMENT HOLDER HAD TO BE FILED DOWN AROUND THIS CIRCLE INSET IN ORDER TO GET THE INSTRUMENT HOLDER TO SIT FLUSH ONTO THE ROBOT ARM. IT WAS DETERMINED THAT THE ROBOT ARM HAD NO ISSUE AS THE POINTER PROBE AND LASER ATTACHMENTS SAT FLUSH WITH NO FORCE NEEDED. THE PROCESS OF GETTING THE INSTRUMENT HOLDER ATTACHED TO THE ROBOT ARM DELAYED SURGERY BY 30-45 MINUTES WHILE THE PATIENT WAS UNDER ANESTHESIA." } ], "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": "05/28/2021" } ] }