ETHICON ENDO-SURGERY, LLC. OPT BLADELESS 5X100 STABILITY; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
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Catalog Number 2B5LT |
Device Problem
Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/01/2024 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Date sent: 4/18/2024 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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Event Description
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It was reported that during a low anterior resection procedure, the trocar completely broke off and went into the patient.Able to retrieve the part with no patient harm.Procedure completed successfully.
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Manufacturer Narrative
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(b)(4).Date sent: 5/28/2024 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 the 2b5lt device was received with the sleeve broken.In addition, the piece broken from the sleeve was returned inside a plastic bag.No conclusion could be reached regarding what may have caused the reported incident.One possible cause for the damage found may be due to excessive force being applied to the device.Please refer to the instructions for use for additional information regarding proper device usage.A manufacturing record evaluation was performed for the finished device lot 777c58 number, and no non-conformances were identified.
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Search Alerts/Recalls
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