SMITH & NEPHEW, INC. LIGHT SOURCE 500XL XENON; IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE
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Model Number 72200568 |
Device Problem
Poor Quality Image (1408)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/17/2022 |
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 an unknown procedure, the image of a light source flashed.Surgery was resumed with a delay greater than 30 minutes, using a the same device.No other complications were reported.
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Manufacturer Narrative
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B5, event description: updated.
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Event Description
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It was reported that, during an acl reconstruction and meniscus repair surgery, the image of a light source flashed.Surgery was resumed with a delay greater than 30 minutes, using a the same device.No other complications were reported.
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Event Description
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It was reported that, during an acl reconstruction and meniscus repair surgery, the image of a light source flashed.Surgery was resumed with a delay greater than 30 minutes, using the same device.No other complications were reported.
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Manufacturer Narrative
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Internal complaint reference case-(b)(4).B5: updated.H10 h3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.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.There was no way to determine if the device contributed to the reported event.The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Factors, unrelated to the manufacturing and design of the device that could have contributed to the reported event, include a faulty lamp, or other component failure.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 investigation will be reopened for evaluation.
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Search Alerts/Recalls
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