ETHICON ENDO-SURGERY, LLC. ENDOPATH XCEL BLADELESS TROCAR; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
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Catalog Number B12LT |
Device Problem
Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/21/2024 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Date sent: 3/7/2024.Batch # unk.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances 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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It was reported that during an unknown surgery, after inserting into the trocar, it was 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: 5/15/2024.D4: batch # x96556.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 b12lt device was received with the tip of the sleeve damaged melted and scratches.Upon evaluation of the device, the tip of the obturator was found cracked damaged.The event reported was confirmed and it is related to improper use of the device.In order to prevent this kind of damage please avoid the contact with laser, electrosurgical or ultrasonic devices.A manufacturing record evaluation was performed for the finished device batch and lot number, and no non-conformances were identified.
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