ETHICON ENDO-SURGERY, LLC. ENDOPATH XCEL BLADELESS TROCAR; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
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Model Number B5LT |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/07/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Investigation summary: the analysis results found that the b5lt device was returned inside its package.The package was returned partially open.Upon visual inspection, the blister and the tyvek were returned with no apparent damage.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.The event described could not be confirmed as the packaging was returned with no apparent damage.
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Event Description
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It was reported that during an unknown procedure, it was noted the packaging was damaged, compromising the sterility.The device was not used on the patient.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.
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Search Alerts/Recalls
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