It was reported that during a gastric sleeve resection, before firing the clip applier, the clips detached from the jaws of the applier.As a result, clips could not be placed on the tissue.Patient lost blood.New device was opened and procedure continued.Procedure prolonged 5 min.
|
(b)(4).Date sent: 10/5/2023.D4: batch #: a9c56t.Additional information was requested and the following was obtained: "was there any other issue noted with the staple line other than bleeding (malformed clips, etc.)? no.How was the bleeding controlled? unknown.How much blood was lost (ml)? unknown.Did the patient require a transfusion? no.Was there any patient consequence or change in the post-operative care of the patient as a result of the event? (extended hospital stay, readmission, re-operation, etc.) no." investigation summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the er320 device was returned for analysis and upon inspection, the jaws were found to be in a yielded condition. in an attempt to replicate the reported incident the device was functionally evaluated.Upon firing of the device, the remaining 7 clips were ejected due to the condition of the jaws; finally the instrument locked out as intended. the event reported was confirmed and it is related to improper use of the device.Possible causes for the found condition of the yielded jaws maybe if the device is closed over an existing hard object or clip placing stress on the jaws causing them to distort or yield and not return to their original dimensions/position or excessive application of torque to the jaws when positioning the device on a vessel. please reference the instruction for use for more information.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.
|