SMITH & NEPHEW, INC. LIGHT SOURCE, 500XL, XENON; IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE
|
Back to Search Results |
|
Model Number 72200568 |
Device Problem
Smoking (1585)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 05/03/2022 |
Event Type
malfunction
|
Event Description
|
It was reported that, during an arthroscopy, while the patient was anesthetized, after switching on the light source console and plugging in the cable, it started to produce smoke from the sides and behind.The error message on the display was: ¿lamp fail.E13".The procedure was completed using a competitor device.An unspecified delay was reported.No patient complications were reported.
|
|
Manufacturer Narrative
|
Internal complaint reference (b)(4).
|
|
Manufacturer Narrative
|
H6: the reported device was not returned to the designated complaint facility for independent evaluation, thus visual inspection and functional testing could not be performed.There was no relationship found between the device and the reported event.The complaint was not confirmed.Factors that could have contributed to the reported event include failure of a concomitant device.A review of device records shows there are 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 found similar reported events.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.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 re-opened for evaluation.
|
|
Search Alerts/Recalls
|
|
|