Model Number TT012 |
Device Problems
Crack (1135); Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/26/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Batch #: unknown.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.
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Event Description
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It was reported that during an unknown procedure, one of devices was broken off when a camera was removed through it.The procedure was thoracoscopic surgery for pulmonary malignant tumor.The tip of the sleeve was broken.The broken pieces was retrieved from the patient.Doctor thought the trocar may be broken when sandwiched between the camera and costa.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.
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Manufacturer Narrative
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(b)(4).Date sent: 12/21/2020.H2: additional information received: the procedure was thoracoscopic surgery for pulmonary malignant tumor.The tip of the sleeve was broken.The broken piece was retrieved from the patient.Doctor thought the trocar may be broken when was sandwiched between the camera and costa.
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Search Alerts/Recalls
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