Model Number ROB10024 |
Device Problems
Computer Software Problem (1112); Application Program Problem: Parameter Calculation Error (1449)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/03/2021 |
Event Type
malfunction
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Event Description
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It was reported that, during a cori tka, prior to starting the case, while on the camera adjustment orientation screen, the screen must have been accidentally touched to move backwards and while doing so, the ¿i¿ (information screen) was stuck.So, they pressed the back button and it took them back to the system preferences page, when sales rep clicked next it would take her back to the ¿i¿ screen and would not allow her to proceed.This process was done a couple times before opting to quit out of the case, pressing resume, re-calibrating and proceeding with the case.Then, when arriving at the implant placement screen the two bottom images of the tibia had a square on top of the image making it difficult to see what you are planning.No error messages displayed on the implant planning screen when error occurred.The surgeon needed to switch implant types from xr to cr and when making that switch the error resolved itself.No further intervention was needed.No cuts were made prior to changing implant type.No patient was harmed by either of these errors and the delay to the case was fewer than 30 minutes.No other complications were reported.
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Manufacturer Narrative
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H3, h6: the real intelligence cori, pn: rob10024, sn: (b)(6) used for treatment was not returned to the designated complaint unit for evaluation, therefore visual and functional inspections could not be performed.The software files were downloaded from the device and provided for investigation.Screenshot review confirmed the user going back and forth between the ¿adjust camera¿ and ¿select surgical preferences¿ screens, and that the ¿next¿ button was enabled.The ¿camera orientation screen¿ is still visible underneath the overlay of the ¿information screen¿ and it stated that the femur and tibia trackers were not visible.Therefore, progressing in the workflow was disabled, and the system operated as intended.Screenshot review also confirmed the block model on the tibia in the ¿implant planning¿ screen for the xr implant.This is a known software issue that is under investigation.This situation is captured in the risk assessment released at the time of the complaint.The failure mode and associated risk have been anticipated within the risk file and that the documented risk level is still adequate.A review of manufacturing records indicate the software met all specifications upon release into distribution.A complaint history review found similar reports.A review of prior escalation actions was performed and found no actions that are applicable to the scope of the reported complaint.This issue will be continuously monitored through complaint investigation and post market surveillance.
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Search Alerts/Recalls
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