ETHICON ENDO-SURGERY, LLC. ENDOPATH*THORACIC TROCAR SLEEV; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
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Model Number TT012 |
Device Problem
Material Separation (1562)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Additional information: attempts are being made to obtain the following information and the following was received: was the thoracoscope with tiny incision the planned procedure?or was the tiny incision only created to retrieve the pieces of the trocar? no further information is available.No further information will be provided.Investigation summary the analysis results found that the tt012 instrument was received with the sleeve broken.One potential cause for the damage found may be the inadvertent application of excessive force or torquing during insertion into the abdominal cavity.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.
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Manufacturer Narrative
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(b)(4).Batch # unk.Date of event is unknown.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.
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Event Description
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It was reported by the sales rep that during a thoracoscope with tiny incision procedure, the device was broken off.The broken pieces were retrieved by surgeon via the trocar and tiny incision, and no pieces were left inside the patient.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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Search Alerts/Recalls
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