SMITH & NEPHEW, INC. LIGHT SOURCE 500XL XENON; IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE
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Model Number 72200568 |
Device Problems
Overheating of Device (1437); Protective Measures Problem (3015)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/16/2021 |
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 failed, error e13.No case reported; therefore, there was no patient involvement.
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Manufacturer Narrative
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H3, h6: the reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.The complaint of an e-13 error was confirmed.Cause of error is a defective mcu pcb.Unit passes functional testing and fans perform as expected with a known good mcu pcb installed.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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Manufacturer Narrative
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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.Factors, unrelated to the manufacturing and design of the device that could have contributed to the reported event, include poor ventilation due to external obstructions to vents or excessive dust buildup on rear fans or fan guards.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future occurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
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Search Alerts/Recalls
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