It was reported that during a colectomy procedure, when closing the banner and advancing the blade until the end it got stuck, without being able to open the jaw again.To open the jaw, the handle must be forced.The device was changed to a new one in order to finish the procedure.No patient consequence reported.
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(b)(4).Batch # p9376z.Investigation summary: the device was received the upper jaw damaged at the proximal side and with the cable cut off.Due to the cable having been cut off, we were unable to perform functional testing.The condition of the jaws prevented the functioning of the jaws.The device was unable to cycle opened and closed.A probable cause of the damage to the jaw could be not allowing thick and fibrous tissues to denature prior to i-blade advancement.The batch history record was reviewed, and no defects, nc¿s or protocols related to the complaint, were found during the manufacturing process.
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