Model Number EIC7070-01 |
Device Problems
Melted (1385); Activation Failure (3270)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/23/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference case-(b)(4).
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Event Description
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It was reported that during a laryngeal surgery, the coblation wand failed to coagulate and it presented three metal wires fused, the setting used on the controller was ablation: 7; coagulation: 3.The procedure was completed by changing the surgical technique for electrocoagulation for homeostasis, and with a 31-minute surgical delay.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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Internal complaint reference: (b)(4).H10 h3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.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.An analysis of the customer provided images found a coblation wand and an image of the tip with burned electrodes.The root cause has been associated with unintended use of the device.Factors that could have contributed to the failure include activating the device above recommended settings for prolonged periods of time.No containment or corrective actions are recommended at this time.
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Search Alerts/Recalls
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