SMITH & NEPHEW, INC. SVCE REPL LIGHT SOURCE LED 3000; IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE
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Catalog Number 72204011S |
Device Problem
Failure to Power Up (1476)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/14/2020 |
Event Type
malfunction
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Event Description
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It was reported that the light source was not turning 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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H10: h3, h6: the reported device, intended for use in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection found unit without external damage.The reported malfunction was not duplicated during the functional evaluation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was a repeat issue.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.
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Search Alerts/Recalls
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