ARTHROCARE CORPORATION WEREWOLF FLOW 90 COBLATION WAND; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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Model Number 72290038 |
Device Problems
Suction Problem (2170); No Flow (2991)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/11/2023 |
Event Type
malfunction
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Event Description
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It was reported that during a shoulder acromion decompression, four (4) werewolf coblation wands failed (all from lot no.2106316) in the same way.There was no suction and no flow out of the wands, but the machine did make a sound.The procedure was completed with a delay greater than 30 minutes, using a back-up device.No further 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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H10: internal complaint reference (b)(4).H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.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.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.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 reopened for evaluation.
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Search Alerts/Recalls
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