(b)(4).Date sent: 8/13/2023.D4: batch # a9c633.Additional information was requested and the following was obtained: "did any pieces fall into the patient? - no, it was not used.It was founded before insertion.If yes, were they retrieved? will all pieces be returned with the device? - yes.If no, were they discarded? were there any patient consequences? if yes, please describe.- it¿s unknown." investigation summary the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that the b11lt device was received with the tip of the sleeve damaged melted.The event reported was confirmed and it is related to improper use of the device.In order to prevent this kind of damage please avoid the contact with laser, electrosurgical or ultrasonic devices.As part of ethicon¿s quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch and lot number, and no non-conformances were identified.
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