Model Number N/A |
Device Problem
Device Difficult to Setup or Prepare (1487)
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Patient Problem
No Code Available (3191)
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Event Date 11/20/2017 |
Event Type
Injury
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Manufacturer Narrative
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The device br16019 and its optical distance sensor have not been evaluated yet for investigation purpose.Once the evaluation will be performed, a follow-up medwatch report will be submitted.(b)(4).
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Event Description
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It was reported that dr.(b)(6) and prof.(b)(6) experienced an issue with the laser registration.The medtech representative arrived on site two hours after the beginning of the surgery, and found out that the operating lights were disturbing the optical distance sensor.Regarding the clinical impact for the patient, nothing has been observed or reported by the surgeons.
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Manufacturer Narrative
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It was reported that it was difficult to perform the contacless registration.The cause for optical distance sensor defect is probably operating lights which were shining the scanning area.There are recommendations in the ifu regarding this issue.The root cause for this issue is that user did not follow ifu recommendations.
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Search Alerts/Recalls
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