(b)(4).Batch # unk.The lot/ batch was not provided; therefore, a manufacturing record evaluation could not be performed.Additional information received: additional information was requested and the following was obtained: how was it discovered or identified that the trocar sleeve had been left behind in patient? ct chest showed collection of fluid/abscess/port warranting return to surgery? did the patient have any symptoms due to the trocar sleeve being left behind in patient? elevated wbcs, signs and symptoms of infection? what was the specific location (in the patient) of the trocar that was retrieved during reoperation? the chest was the trocar sleeve trimmed prior to use during the initial procedure? no.Was the trocar sleeve sutured or stapled in place to secure it before use? yes, it was sutured.The hole that secured the trocar was ripped, so the suture did not keep the trocar from falling in the patient.Was the entire trocar sleeve retrieved from the patient? yes or was there only a piece left behind that was retrieved from the patient? n/a.How do you know that the entire trocar sleeve was retrieved from the patient and that no additional piece was still retained? visualized by surgeon.What instrument or instruments were passed through the trocar sleeve? the scope.Were there any difficulties passing instruments through this trocar sleeve? no.Is the surgeon alleging any deficiencies of the flexipath trocar? yes.If so, what specifically are the alleged deficiencies? yes, the flange should be more rigid.Was the retrieved trocar saved from reoperation and if so, can it be sent back to ethicon for analysis? sent to pathology.Are there any photos available that can be shared for review? no.Are there any x-rays available that can be shared for review? no.
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