(b)(4).Date sent: 3/22/3035.D4 batch #: a9dy2x.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 determined that the device was returned with the tissue pad damaged, with a staple embedded.The blade tip was tip off and returned this blade tip portion may have broken off of the device during transport to our analysis site.The device was connected to a gen11 and the device did activate during functional testing. additionally, photos were provided and they showed the condition of the reported event. the device was disassembled to inspect the internal components and no anomalies were found. if the device is activated across a clip, staple line, or other metal in the jaws, the blade and the tissue pad could get damaged.Subsequent activations may increase the severity of the blade damage.Once minor blade damage has occurred can result in activation issues such as failing the pre-run test with the generator and displaying an alert screen.These alert screens that can result are such ¿blade error detected¿ or "relaxed pressure on blade" followed by a ¿replace instrument¿ screen later in the procedure.Continued usage of the damaged blade can result in a broken blade.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch a9dy2x, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.
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