SMITH & NEPHEW, INC. SVCE REPL LIGHT SOURCE 500XL XENON; IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE
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Model Number 72200568S |
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 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 set up or inspection for an unknown surgery the light source 500xl xenon was showing a e12 error when turned on, it was unable to get any light.The procedure was successfully completed without delay using a back-up device.No patient injury or other complications were reported.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 visual inspection was performed on the exterior of product and no physical damage was observed.There was a relationship found between the returned device and the reported incident.The complaint of e12 error and overheating was confirmed.The complaint investigation has concluded that the cause of the overheating and e12 errors is 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.
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Search Alerts/Recalls
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