(b)(4).Date sent: 3/22/2024.D4 batch #: a9dp4r.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 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.In addition, the device was returned with the tissue pad with signs of normal wear and properly attached to the clamp arm.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 stop activating and display an alert screen is blade damage.The device was disassembled to verify 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. once minor blade damage has occurred, subsequent activations may increase the severity of the blade damage.This in turn 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 as "remove instrument from patient" or ¿blade error detected¿ or "relaxed pressure on blade" followed by a ¿replace instrument¿ screen later in the procedure.Continued usage of the damage blade can result in a broken blade.Additionally, photos were provided and they showed the condition of the reported event.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 a9dp4r, and no non-conformances were identified.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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