Model Number ROB10016 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/31/2022 |
Event Type
malfunction
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Event Description
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It was reported that when burring during a cori assisted ukr surgery, the real intelligence robotic drill guard broke.No pieces fell inside the patient.The procedure was completed, with a non-significant delay, using a s+n back-up device.
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Manufacturer Narrative
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Section h10: the real intelligence robotic drill guard used for treatment was not returned for evaluation; thus, a visual and functional evaluation could not be performed, and a relationship between the reported event and the device could not be established.While all products meet required manufacturing specifications prior to release a serial number or lot number is required to link the device to a dhr or nc investigation.A complaint history review for similar reported/confirmed complaints found similar events.Although the reported problem was not confirmed a factor that may have contributed to the reported symptom may have been associated with an incomplete weld around the perimeter of the irrigation tube.A historical escalation event review was not completed.The product was not returned and no evidence was made available to link the complaint to an escalation event.Refer to the product instructions for use "recovery procedure guidelines" table that provides guidelines for recovering to a fully manual procedure in the event of an unrecoverable hardware failure.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.If the product associated with this event is returned or provided at a future date, this evaluation will be reopened for investigation.Internal complaint reference number: (b)(4).
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Manufacturer Narrative
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The manufacturer has identified that this event should be re-evaluated for mdr reporting.The detached component is of a size/shape that can be easily retrieved in its entirety and this malfunction has been resolved by using an available back-up device.Although this event may result in a short delay while the procedure is resumed and completed as intended, this malfunction has not caused or contributed, in the past, to a death or serious injury, nor has it been required a medical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.This malfunction is unlikely to cause any death or serious injury if it were to recur, either.Therefore, this event is considered non-reportable pursuant to 21 c.F.R.§803.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly, and a further report submitted outlining both the event details and our investigations performed.
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Search Alerts/Recalls
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