ARTHROCARE CORPORATION WEREWOLF APL CONTROLLER (RF20000-APL); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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Catalog Number 72290146 |
Device Problems
Overheating of Device (1437); Intermittent Energy Output (4025)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/12/2023 |
Event Type
malfunction
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Event Description
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It was reported that the werewolf controller had an intermittent malfunction, it was very hot and was not running.No case was reported, therefore, there was not patient involvement.
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Manufacturer Narrative
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H10: internal complaint reference: (b)(4).
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Manufacturer Narrative
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H10: h3, h6: the reported device was received for evaluation.A visual inspection revealed no issues.Functional evaluation revealed no issues.No heat related issues occurred.The temperature sensor was at normal levels and the output was at expected levels.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause could not be determined since the reported malfunction could not be duplicated during the investigation.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.
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Search Alerts/Recalls
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