Model Number 72290038 |
Device Problem
Failure to Shut Off (2939)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/14/2022 |
Event Type
malfunction
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Event Description
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It was reported that during a total knee arthroplasty procedure using werewolf coblation wand, there was continuous triggering of the coblation function (yellow).The procedure was completed with non-significant surgical delay using a back-up device.No patient complications were reported.
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Manufacturer Narrative
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H3, h6: the reported device was received for evaluation.There was no relationship found between the device and the reported event.A visual inspection of the returned instrument shows no manufacturing abnormalities.No visual issues were observed.Product was returned in original packaging opened.The data extracted revealed that the wand was activated previously.No error recorded.A functional evaluation revealed the wand was able to generate plasma and coagulation.The yellow button performed as intended.The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Factors that could have contributed to the reported event include a failure of a concomitant device.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.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.
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Search Alerts/Recalls
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