SMITH & NEPHEW, INC. MOTOR DRIVE UNIT HAND CNTRL PWRMX EL; SAW, POWERED, AND ACCESSORIES
|
Back to Search Results |
|
Model Number 72200616 |
Device Problem
Failure to Power Up (1476)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Internal complaint reference (b)(4).The sample is under evaluation by the manufacturing site.
|
|
Event Description
|
It was reported that the motor drive unit had an error message when it was plugged in.The incident occurred before the procedure.There was no delay and a backup device was available to complete the procedure with no complications reported.Preliminary results of investigation have concluded that this unit had a button not activating the motor which makes it a reportable event.
|
|
Manufacturer Narrative
|
The reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the product and observed no issues.A functional evaluation revealed a button was stuck and would not activate the motor causing a hand piece error.The complaint was confirmed and the root cause has been associated with a mechanical component failure.Factors that could have contributed to the event include a buildup of corrosion/debris around the spring from cleaning chemical fluid ingression over time.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
|
|
|