SMITH & NEPHEW, INC. LIGHT SOURCE 500XL XENON; IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE
|
Back to Search Results |
|
Model Number 72200568 |
Device Problem
Failure to Power Up (1476)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Reference: case (b)(4).
|
|
Event Description
|
It was reported that the light source´s power did not turn 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.
|
|
Manufacturer Narrative
|
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 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 which could have contributed to the reported event, include a defective power supply/ballast or other related electrical components.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.
|
|
Manufacturer Narrative
|
Internal complaint reference: (b)(4).H3, h6: the reported device, intended for use in treatment, was received for evaluation.A visual inspection was performed on the product and the lid and front bezel were observed to be damaged.There was a relationship found between the returned device and the reported incident.Product failed to power up.Cause of power failure is a defective power supply.The complaint was confirmed and the root cause has been determined 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.
|
|
Search Alerts/Recalls
|
|
|