Model Number ROBOT ARM |
Device Problem
Unintended Arm Motion (1033)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/22/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not been evaluated yet for investigation purpose.Once the evaluation will be performed, a follow-up medwatch report will be submitted.
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Event Description
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Surgeon is concerned that the robot arm allows too much unwanted movement when drilling and placing the ablation bolt, which is causing placement error.This unwanted movement happens when the robot arm is extended and the vigilance device is off (i.E.The robot is not powered).Cst noticed that there may be an abnormal amount of movement.
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Manufacturer Narrative
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It was reported that it was noticed that the robot arm allowed too much movements when drilling or placing bolts.Dhr review did not identify any contributory factors to the event.Review of complaint history showed that 2 complaints for inaccuracies were received for this device.The investigation on those complaints showed that a failure of the device was not the cause of the inaccuracies.According to technical investigation there is no test available to check if the robot arm is out of specifications.However the event is confirmed by the surgeon, the field service engineer on site and by r&d and field service department through the review of videos of the event.The device ro15064 was removed from the hospital as part of zfa 2018-00194 and is no longer used.Incoming complaints for this device will be monitored.Corrected data: - b4 date of this report - d4 additional device information - catalog number - g1-2 contact office - manufacturing site - g4 date received by manufacturer (completion of the technical investigation) - h2 if follow-up, what type - h3 device evaluated by manufacturer - h6 evaluation code - h7 remedial action.
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Event Description
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Surgeon is concerned that the robot arm allows too much unwanted movement when drilling and placing the ablation bolt, which is causing placement error.This unwanted movement happens when the robot arm is extended and the vigilance device is off (i.E.The robot is not powered).Field service engineer noticed that there may be an abnormal amount of movement.
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Search Alerts/Recalls
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