Model Number ROB10015 |
Device Problems
Break (1069); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/18/2022 |
Event Type
malfunction
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Event Description
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It was reported that, during washing in the spd, the plastic lining came out of the ri robotic drill attachment.No case involved; therefore, there was no patient involvement.
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Manufacturer Narrative
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Internal complaint reference: case (b)(4).
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Manufacturer Narrative
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Internal complaint reference: case (b)(4).
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Event Description
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It was reported that, during washing in the spd, the plastic lining came out of the ri robotic drill attachment.No case involved; therefore, there was no patient involvement.
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Event Description
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It was reported that, during washing in spd, the plastic lining (wiper) came out of the ri robotic drill attachment.No case involved; therefore, there was no patient involvement.According to the investigation findings, the wiper was missing, and no evidence of epoxy was identified.
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Manufacturer Narrative
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H10: additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that the plastic lining (wiper) was missing, and that no evidence of epoxy was identified.Therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.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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