(b)(4).Date sent: 8/28/2023.B3: unknown, assumed first day of month that complaint was reported.D4: batch # unk.Additional information was requested and the following was obtained: "did any pieces fall into the patient? yes.If yes, were they retrieved? yes.Will all pieces be returned with the device? yes." 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 b5lt device was received with the tip of the sleeve broken and damaged melted.The piece from the sleeve was returned inside aplastic bag.In addition, the tyvek was returned along with the instrument.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.One possible cause for the damage found may be due to excessive force being applied to the device.Please refer to the instructions for use for additional information regarding proper device usage.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 lot number, and no non-conformances were identified.
|