ARTHROCARE CORP. WEREWOLF FLOW 90 COBLATION WAND; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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Model Number 72290038 |
Device Problems
Failure to Shut Off (2939); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/25/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Event Description
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It was reported that, during an unknown procedure, a werewolf coblation wand remained activated, the light blue selector button of the wand got stuck in the slot.In addition, an error message was displayed.Surgery was resumed, after a non-significant delay, with the same device.No further complications were reported.
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Manufacturer Narrative
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H2: additional information ¿b5¿.
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Event Description
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It was reported that, during a shoulder rotator cuff repair, a werewolf coblation wand remained activated, the light blue selector button of the wand got stuck in the slot.The sticking button caused the handpiece to generate plasma continuously without activation.In addition, an error message of several buttons pressed at the same time, was displayed.Surgery was resumed, after a non-significant delay, with the same device.No further complications were reported.
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Manufacturer Narrative
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H3, h6: the reported device was received for evaluation.There was a 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 out of the original packaging.No packaging returned.The data extracted revealed the wand was activated previously and experienced a "multiple button pressed notification" error.Device was tested, and generated plasma and coagulation as intended.The hand controls performed, no stiffness.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.The complaint was confirmed for multiple button error and the root cause was associated with unintended use of the device.There was no sticking observed to confirm.Factors that could have contributed to the reported event include: 1)the wand´s connector or cable got damaged.2) saline/humidity entered the interior of the handle shorting the connection of the buttons.No containment or corrective actions are recommended at this time.
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Search Alerts/Recalls
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