SMITH & NEPHEW, INC. LENS INTEGRATED SYSTEM WIFI VERSION; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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Catalog Number 72204354 |
Device Problem
Smoking (1585)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/18/2019 |
Event Type
malfunction
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Event Description
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It was reported that smoke was coming out of the lens integrated system.Incident occurred before the procedure; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Event Description
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Hold by ema 1/3/2020.
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Manufacturer Narrative
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The reported device, intended for use in treatment, was received for evaluation.A visual inspection was performed on the exterior of product and no physical damage was observed.Complaint of burnt odor was confirmed.Cause of burnt odor is a burnt capacitor on the dsp pcb.Product passed functional testing.The complaint was confirmed and the root cause has been determined to be a burnt capacitor on the dsp pcb.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.
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