ETHICON ENDO-SURGERY, LLC. 12MM XCEL STABILITY SLEEVE; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
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Catalog Number CB12LT |
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 02/14/2024 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Date sent: 3/5/2024.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 procedure, the silicon on the inside of the trocar was not cut properly which wasn't allowing instruments to be able to pass through.Replaced with another device to proceed with the case.No patient harm.
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Manufacturer Narrative
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(b)(4).Date sent: 3/26/2024.D4: batch # unk.Investigation summary.The product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the cb12lt device was returned with no damage to the external components.In an attempt to replicate the reported incident, the device was tested for functionality.Upon testing s test obturator was attempted to be introduced into the sleeve assembly however, it could not be introduced due to a closed duckbill.The device was disassembled in order to evaluate the condition of the duckbill and the closed duckbill was confirmed.It is possible that this event was caused by a failure to detect the closed duckbill during the manufacturing process.The reported complaint was confirmed.The manufacturing records couldn't be reviewed as the batch number is unknown.
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