ETHICON ENDO-SURGERY, LLC. ENDOPATH XCEL BLADELESS TROCAR; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
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Catalog Number B12LT |
Device Problems
Crack (1135); Gas/Air Leak (2946)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/21/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Date sent: 9/27/2023.D4: batch # unk.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Event Description
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When trying to introduce the trocar into the navel, and then insufflate the pneumo, a lot of resistance is felt, the trocar is removed and it is evident that the tip is bent so that it prevented the passage of the same.No patient consequences.
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Search Alerts/Recalls
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