It was reported that during a tonsillectomy the evac 70 coblation wand was not working, after procedure on the first tonsil, the surgeon noticed that one of the filaments at the end of the probe was broken.The broken piece had to be aspirated, no broken parts were left in the patient.The procedure was completed with 10 minutes of surgical delay using a smith and nephew back up device.The patient is well and no further complications were reported.
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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.The electrode is detached on one side.Product was out of the original packaging.No packaging returned.Visual inspection of the customer provided picture shows the same wand tip with the electrode broken off on one side.The opened device was tested and plugged into the controller and registered settings (7,3).Which indicates the unit still had life uses.A bypass box was used with the wand and a low amount of plasma was observed due to the damaged electrode.The complaint was confirmed and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include: hitting the device tip against a hard surface.Using the device as a lever to enlarge surgical site.Mechanical displacement of tissue through applied force.A clinical review found this case reports the breakage of ¿one of the filaments at the end of the probe¿ broke during the tonsillectomy procedure.The provided undated/unlabeled photo was reviewed and appears to show 3 broken electrodes at the tip of the wand.As of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have definitively contributed to the event.The patient impact beyond the reported is not anticipated as ¿the broken piece had to be aspirated, no broken parts were left in the patient.¿ per case communication ¿the surgeon checked to see if there was anything left in the mouth, no part of the probe remained in the mouth.¿ ¿everything went into the suction.¿ it was further communicated the procedure was completed with a smith and nephew backup device following a 10-minute surgical delay.Reportedly, the patient is ¿doing well (normal food intake at day 4, no bleeding).¿ no further complications were reported, or patient injury alleged.Therefore, no further clinical/medical assessment is warranted.A review of the device history records show there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review found no similar reported events.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.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.No containment or corrective actions are recommended at this time.
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