During robotic surgery, trocar used for scope is broken.The reason is that when the temperature rises due to the light and the material of the melted trocars is put in and out of the apparatus, it is presumed that a physical bump has occurred and broken, there were no patient consequences.
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(b)(4).Batch # p91z1j.Device analysis: the analysis results found that the b12xt instrument was received with the sleeve melted.In addition, the tyvek was returned along with the instrument.This type of damage is consistent with the one produced by an energized device.In order to prevent this kind of damage please avoid the contact with laser, electrosurgical or ultrasonic devices.The lot history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the packaging process.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.
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