SMITH & NEPHEW, INC. LIGHT SOURCE 500XL XENON; IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE
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Model Number 72200568 |
Device Problem
Overheating of Device (1437)
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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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Internal complaint reference (b)(4).
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Event Description
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It was reported that the light source's the device was overheating.No case reported; therefore, there was no patient involvement.
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Manufacturer Narrative
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H10: internal complaint reference: (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection was performed on the exterior of the device and the lid was not seated correctly, rear lid to case screws were missing, threads for retaining a screw had been stripped and the case scratched.No lamp was returned with the device.A functional test revealed that the lamp fan turns off when the device is in active mode.The fan cables were observed to have been reversed on the sensor board.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.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.It was determined the device did not contribute to the reported event.The complaint was confirmed and the root cause was associated with unintended use of the device.Factors, unrelated to the manufacturing and design of the device that could have contributed to the reported event, include inadvertently reversing the fan cables resulting in overheating due to the lamp fan shutting down.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.
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Search Alerts/Recalls
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