(b)(4).Should the information be provided later, a supplemental medwatch will be sent.Additional information: which generator was used with the device gen04 or gen11? gen 11.Were there any error messages and if so what were they? : requested but not provided.Did the device pass the pre test? : yes.Did the device activate? : requested but not provided.Had the device been working and then stopped? : yes.Was there an issue with the activation buttons?: requested but not provided the device was returned with the distal tip of the blade broken off and not returned.The remaining blade portion was scratched, evidence of contact with metal in or out of the operative field.The device was functionally tested with a generator.During functional testing on gen11 an alert screen was displayed.A probable cause of the device stop activating and display an alert screen is blade damage.Probable causes of blade damage, including breakage, are external contact during pre-op or general use, blade contact with other devices, staples or clips during the procedure or using any means other than the blade wrench to attach or detach the blade.Once minor blade damage has occurred, subsequent activations may increase damage severity and result in alert screens, such as ¿tighten assembly¿, ¿blade error detected¿ or "relaxed pressure on blade" followed by a ¿replace instrument¿ screen later in the procedure.
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