(b)(4).Batch # x95823.Investigation summary : the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the nslg2c25 device was returned with the bottom portion of the i blade out of the lower jaw channel; the lower jaw channel was damaged.The pc and the i blade were not damaged as reported.The device was connected to the generator and it was recognized.Because of the condition of the device not all functional testing could be performed with the generator.The jaw was unable to cycle open and close.A probable cause of the damage to the jaw could be not allowing thick and fibrous tissues to denature prior to i-blade advancement.As described in the ifu: do not use excessive force on the closing handle to close the jaws; grasp only as much tissue as will fit between the jaws where the current will pass.Greater amounts of tissue require more closing handle force.Excessive force could damage the device.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch x95823, and no non-conformance were identified.Additional information was requested, and the following was obtained: did the generator display any error messages and if so what were they? no.Did the device pass the pre-test? yes.Had the device been working and then stopped? yes.Did the patient experience any adverse consequences due to this issue? no.Did the electrode ceramic separate or break off? separate and break off.Did the i blade get damaged or break off? separate.Is the jaw damaged but not broken off? damaged.Is the top jaw loose but not detached? loose.Is the top jaw ptc material damaged? yes.Is the black ptc in the upper jaw detached? yes.Is the top jaw broken off the of the device? no.
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