SMITH & NEPHEW, INC. LIGHT SOURCE 500XL XENON; IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE
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Model Number 72200568 |
Device Problem
Failure to Power Up (1476)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that the "light source (500xl, xe)" did not turn on.No case reported; 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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Manufacturer Narrative
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H3, h6: 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.There was a relationship found between the returned device and the reported incident.The complaint of fan malfunction and overheating was confirmed.The cooling fan for the ballast shuts down when unit is powered up causing overheating and errors.Fan malfunction is caused by a defective electronic component.The complaint investigation has concluded the cause of the failure to be a defective electronic component.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.A complaint history review concluded this was a repeat issue.No containment or corrective actions are recommended at this time.
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Search Alerts/Recalls
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