(b)(4).Batch # t92c4z.Additional information was requested, and the following was obtained: is there a picture or video of the foreign body that retrieved from the patient? i do not have any picture or video, but i sent both the trocar and the reducer cup to be analyzed.Clarification is needed, was the foreign body the dark gray inner seal? yes.Is it believed the ¿cup¿ fell into the patient during the 1st surgery (initial) or during the re-op (2nd procedure)? it is believed that happened during the 1st surgery.During the 2nd procedure was the ¿cup¿ retrieved? yes.Was there any mesh, raytec, or surgical sponges inserted through the trocar during the procedure (initial procedure)? no.What was the specific reason for the re-operation? there was a bleeding on the staple line, identified after the surgery was performed.Is it the hospitals normal routine to reprocess this specific type of trocar? no.Was this trocar re-processed? no.What instruments were passed through the trocar in the initial procedure? normally they passed the laparoscopic lens, our endocutters, instruments like graspers/scissors and also they use the sodium chloride solution bag from baxter to get the part of the stomach they take out of the patient´s body, they use that bag as if that was our pouch.Can the surgeon confirm that the foreign body is not the reason for the re-operation? yes.What product was used on the staple line that was bleeding which lead to the re-operation (please provide the product code)? the surgeon used : echelon powered (psee60a), green reloads (gst60g), blue reloads (gst60b).Device analysis: the analysis results found that the ctb12lt device was returned with the duckbill damaged and out of position.The duckbill was observed to have a mark which suggest that a snagging of an instrument during insertion with excessive force causing the duckbill out of position.Per instructions for use: "use caution when introducing or removing instruments through the trocar sleeve in order to prevent inadvertent damage to the seals which could result in loss of pneumoperitoneum.Special care should be used when inserting sharp or angled edged endoscopic instruments to prevent tearing the seal." a manufacturing record evaluation was performed for the finished device batch t92c4z number, and no non-conformances were identified.
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