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 12/27/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4) date sent: 1/25/2024 d4: batch # unk 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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It was reported that during an unknown surgery, after inserting into the trocar, noted the device was broken.Another device was used to complete the surgery.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: 2/13/2024.D4: batch # a9d109.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 b12srt device was received with the obturator inserted thru the sleeve.Upon evaluation of the device, the clear lens from the obturator were found damage.The sleeve was found without any damaged.The damaged on the clear lens, it is possible that the damaged was due to an improper handling of the device.A manufacturing record evaluation was performed for the finished device batch and lot number, and no non-conformances were identified.
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