SMITH & NEPHEW, INC. LIGHT SOURCE LED 3000; IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE
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Catalog Number 72204011 |
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 Date 10/29/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference (b)(4).
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Event Description
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It was reported that during routing inspection the light source was not turning on.It is unknown if back up device was available and there was no significant delay.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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The reported device, intended for use in treatment, was received for evaluation.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.A visual inspection did not reveal any issue.A functional evaluation revealed the device powers on and the fan starts but there is no light output.All buttons functioned normally.The complaint was confirmed and the root cause was associated with the light engine.
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Manufacturer Narrative
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H10: internal complaint reference: (b)(4).H6: the reported device, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.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.A relationship, if any, between the subject device and the reported event could not be determined.
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