It was reported that during an unknown procedure, after two-three activations of a new ace probe (opened in this surgery), the generator started showing a replace instrument error and did not work even after the troubleshooting steps were followed.Unknown how case was completed.There were no adverse consequences for the patient.
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(b)(4).Information asked for but unknown or not provided during initial contact.Should the information be provided later, a supplemental medwatch will be sent.The device was returned with the distal tip of the blade broken off and not returned.The remaining blade portion was scratched.This blade tip portion may have broken off of the device during transport to our analysis site.The reported complaint was for the generator started showing a replace instrument error.The device was functionally tested with a generator.During functional testing on gen11 an alert screen was displayed.A probable cause of 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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