(b)(4).Batch # n9181d.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.The reported complaint was for: "the device could not be activated".During functional testing on gen11 an alert screen was displayed.In addition, it was noted that the max hand control button was nonfunctional.A probable cause of the device stop activating and display an alert screen is blade damage.The instrument was disassembled to inspect the internal components and the electrical traces of the max hand control button were found to be damaged.This resulted in the max hand control button to be nonfunctional.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.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.No conclusion could be reached as to what caused the electrical traces issue.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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