ETHICON ENDO-SURGERY, LLC. ENDOPATH XCEL BLADELESS TROCAR; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
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Catalog Number B12SRT |
Device Problem
Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/13/2023 |
Event Type
malfunction
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Event Description
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It was reported that during an aortic valve replacement, when a device was put in and out of the trocar, the distal part of the trocar was partially cracked.Fragment removed from the body, and replaced with new trocar to continue the operation.There was no patient consequence reported.No additional information could be provided.
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Manufacturer Narrative
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(b)(4).Date sent:8/13/2023 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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Manufacturer Narrative
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(b)(4).Date sent: 9/20/2023.D4: batch #: a9c15x.Investigation summary : the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that the b12srt device was received with the tip of the sleeve broken and no piece were returned.No conclusion could be reached regarding what may have caused the reported incident.One possible cause for the damage found may be due to excessive force being applied to the device.Please refer to the instructions for use for additional information regarding proper device usage.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch and lot number, and no non-conformances were identified.
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