(b)(4).Batch # n90d3h.The device was returned with the distal tip of the blade broken off and it was returned with the device.The remaining blade portion was scratched, and with 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.The device was analyzed, and it was determined that it was likely connected in more than one generator.The device is intended and labeled for single patient use.If the device is connected to multiple generators an alert screen will be displayed indicating ¿adaptive tissue technology features are not available in this device¿.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 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.This device is packaged and sterilized for single use only.Multiple patient use may compromise the device integrity or create a risk of contamination that, in turn, may result in patient injury or illness.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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