ARTHROCARE CORP. FA QUANTUM 2 CONTROLLER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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Catalog Number 28168 |
Device Problem
Therapeutic or Diagnostic Output Failure (3023)
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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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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 review of the device history records show 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 concluded this was a repeat issue.Visual inspection observed a scratched lid.Functional evaluation revealed the unit has no output voltage.The unit was opened and found no issues.The complaint was confirmed and the root cause is associated with an electrical component failure.Factors, unrelated to the design or manufacture of the device which could have contributed to the complaint event, include a power surge in the controller or failure of an internal component.
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Event Description
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It was reported that the quantum controller was not accepting the wands appropriately, they were not recognized by the controller.The incident occurred before the procedure.A backup device was available to complete the procedure with no delay or complications 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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H3, h6: internal complaint reference: (b)(4).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 review of the device history records show 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 concluded this was a repeat issue.Visual inspection observed a scratched lid.Functional evaluation revealed the unit has no output voltage.The unit was opened and found no issues.The complaint was confirmed and the root cause is associated with an electrical component failure.Factors, unrelated to the design or manufacture of the device which could have contributed to the complaint event, include a power surge in the controller or failure of an internal component.No containment or corrective actions are recommended at this time.
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Search Alerts/Recalls
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