MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REAL INTELLIGENCE CORI; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number ROB10024

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2023

Event Type  malfunction  

Event Description

Left total knee arthroplasty with computer navigation, was cancelled in the operating room due to cori robot malfunction.Prior to the patient entering the operating room, the rep turned on the cori robot and followed all safety checks and prompts per usual.The patient had received their block and was brought into the operating room and put under general anesthesia.Surgeon then entered the operating room, the final part of the cori check with sterile components failed to complete its final calibration.The decision was made to abort the procedure after multiple attempts to resolve problem, including cori robot specialist consultation.Patient was awoken and transferred to pacu.Surgeon did not make incision.

• Brand Name: REAL INTELLIGENCE CORI
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.
• MDR Report Key: 16204588
• MDR Text Key: 307780335
• Report Number: MW5114370
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROB10024
• Device Catalogue Number: ROB10024
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/18/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CORI HAND PIECE; CORI POINT PROBE; REAL INTELLIGENCE BURR
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 116 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White