(b)(4).Batch #t93418.Investigation summary: the device received was returned with the tissue pad with no apparent damage and the distal tip of the blade broken off and not returned.The remaining blade portion was scratched, and with evidence of contact with metal in or out of the operative field.This blade tip portion may have broken off of the device during transport to our analysis site.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.The device was disassembled to inspect the internal components and no anomalies were found.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.Once minor blade damage has occurred, subsequent activations may increase the severity of the blade damage.This in turn can result in failing the pre-run test with the generator and displaying an alert screen.These alert screens that can result are such as "remove instrument from patient" or ¿blade error detected¿ or "relaxed pressure on blade" followed by a ¿replace instrument¿ screen later in the procedure.Continued usage of the damage blade can result in a broken blade.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.
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It was reported that during an unknown procedure, the device worked fine at the beginning.The instrument did not get in touch with metal or any other hard object.The generator showed an error message.However, the surgeon does not recall what it was.The white teflon pad appeared to come off.No patient consequence reported.
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