Model Number SYNERGY RESECTION SHAVER CONSOLE |
Device Problems
Device Emits Odor (1425); Smoking (1585)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/25/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
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Event Description
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It was reported that the ar-8305 synergy shaver console had a burning smell in the middle of a case and then stopped working.
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Manufacturer Narrative
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(overcurrent condition) the evaluation determined that the reported event was caused by damage to the control board.The damage was attributed to an overcurrent condition.
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Manufacturer Narrative
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(overcurrent condition) complaint confirmed.The evaluation determined that the reported event was due to damage to the control board.The damage was attributed to an overcurrent condition.The cause is due to product design (software).
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Search Alerts/Recalls
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