Model Number 1125 |
Device Problem
Intermittent Loss of Power (4016)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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This mdr is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.The device is pending evaluation.There was no remedial action taken.This device is not labeled for single use.
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Event Description
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This report summarizes 1 malfunction event, where it was reported the zoom disengaged during use. there was no patient involvement.
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Event Description
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This report summarizes 1 malfunction event, where it was reported the zoom disengaged during use. there was no patient involvement.
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Manufacturer Narrative
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Information provided by the customer indicated that there was no defect with the device; the customer could not duplicate the issue.
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Search Alerts/Recalls
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