(b)(4).Batch #: unk.Investigation summary: the analysis results found that the b11lt device was received with the tip of the sleeve melted.In addition, the universal seal was missing.One possible cause for this type of damage may be interaction with an energized device used during the procedure.Caution should be taken to avoid contact between an energized device and the trocar during the surgical 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.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.
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It was reported that during an esophagus procedure, halfway through, the surgeon noticed that the device was dragging when it was pulled back through the trocar.It looked as though there were melted grooves in to the trocar.A second like device was pulled and the procedure was completed with the second trocar.There was no patient consequences.
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