On (b)(6) 2022, it was reported by a sales representative via email that an ar-8330h shaver handpiece caught on fire when it was plugged in and laying on the mayo stand.Shortly after, the room experienced a power outage.An ar-6480 dualwave arthroscopy fluid management system, an ar-8305 synergy resection shaver console, and an ar-9800 synergy rf console were all connected and running during this incident.This was discovered during a procedure.Additional information 10/5/2022: per the sales representative: the hospital¿s biomedical engineer team did their own internal investigation and found that the shaver disposable was bent during the procedure which caused the inner and outer sleeves to create friction and heat and catch fire.On (b)(6) 2023, the complaint reporter provided additional information confirming that the event occurred after the device had been used in the procedure.In addition, it was informed that the disposable was on the mayo stand when someone accidentally stepped on the footswitch and activated the shaver.This information confirmed arthrex's hypothesis that the device had been activated without irrigation, causing the excessive heating of the disposable.On the same day, arthrex assessed the effects of activating disposable attachments without irrigation, affirming that irrigation is essential in maintaining the device at appropriate temperatures during operation.The labeling for disposable attachments, dfu-0215-7, includes two precautions related to running the device without irrigation flow, indicating that doing so will result in irreversible damage, excessive heating, and may cause thermal burns.
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