ETHICON ENDO-SURGERY, LLC. ENDOPATH BLADELESS TROCAR; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
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Catalog Number B12LT |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
Foreign body, removal of (2365)
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Event Date 03/17/2015 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Additional information: the analysis results found that the b12lt device was received with the cap of the sleeve assembly separated, causing its components to be out of position; the components from the sleeve were returned inside a bag, only the spring was not returned.In addition, the obturator cap was observed to be separated and the clear lens was noted to be fractured.The seal from the universal seal was in good condition.A potential cause of this condition is the repeated use of eto as a sterilization agent.Ees single-use trocars are not to be reused, reprocessed or re-sterilized.
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Event Description
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It was reported that during a low anterior resection procedure, the trocar was inserted, and then the robotic arm connected and the camera inserted through the trocar, the procedure started.After about 30 minutes, when retrieving the camera to be cleaned, the seal support of the trocar together with the trocar seal got dislodged.The body of the trocar remained in the patient wall.To continue the procedure the disconnected components of the trocar was fixed with sterile adhesive band in their initial place.The trocar was new.There was no patient consequence.
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Manufacturer Narrative
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(b)(4).No device received for analysis at time of submission of 3500a.When additional information is received and/or the device analysis has been completed, a supplemental medwatch will be sent.
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Search Alerts/Recalls
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