ETHICON ENDO-SURGERY, LLC. ENDOPATH XCEL BLUNT TIP TROCAR; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
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Catalog Number H12LP |
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 04/03/2024 |
Event Type
malfunction
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Event Description
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It was reported that during an unknown procedure, the duckbill valve was damaged.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: 4/23/2024.D4: batch # unk.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: 5/21/2024.D4: batch # a9da17.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 h12lp device was received with the obturator inserted through the sleeve, for this reason the seal mechanism was found to be deformed.The olive plug assembly was found damaged, the olive cap and cam of the olive assembly were returned inside a plastic bag.In addition, the tyvek was returned along with the instrument.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.
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