(b)(4).Batch # r9211k.Investigation summary: the device was returned with 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 stopping activation and displaying an alert screen is blade damage.The device was disassembled to inspect the internal components and no anomalies were found.Blade damage can cause activation issues.Probable causes of blade damage, including breakage, are external contact during pre-op or general use, blade contact with other devices, contact with 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 activation may increase the severity of the blade damage.This, in turn, can result in the device failing the pre-run test with the generator and displaying an alert screen.These alert screens that can result may included ¿tighten assembly,¿ ¿blade error detected,¿ "relax pressure on blade," or " remove instrument from patient," followed by a ¿replace instrument¿ screen later in the procedure.Continued usage of the damaged blade can result in a broken blade.The batch history record was reviewed and there were no defects, protocols or ncr(s) found during the manufacturing process related to this complaint.
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