ETHICON ENDO-SURGERY, LLC. ENDOPATH XCEL BLADELESS TROCAR; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
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Catalog Number B12LT |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/08/2024 |
Event Type
malfunction
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Event Description
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It was reported that during an ob-gyn procedure, duckbill valve came off when inserting the gauze through the trocar.They did not notice soon, but the pneumoperitoneum pressure did not raise, and found the duckbill valve fallen in the abdomen.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.
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Manufacturer Narrative
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(b)(4).Date sent: 2/28/2024.D4: batch # unk.Additional information was requested and the following was obtained: "there were no changes to the surgrey (e.G.Adding a port hole, adding an incision, etc.) when retrieving the valve that had fallen into the body.There are no problems with the patient's condition after the surgery." 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: 3/14/2024.D4: batch # unk.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 only the sleeve from b12lt device was received with the duckbill out of position and present.In addition, the duckbill and universal seal were returned inside a plastic bag.However, it is known from the history of the device that the condition of the duckbill out of position may lead to insufflation issue.No conclusion could be reached as to what might have caused the duckbill out of position.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.
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