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Catalog Number XC200 |
Device Problem
Positioning Failure (1158)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/05/2024 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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.H6 component code: g07002 device not returned.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.Attempts are being 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.
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Event Description
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It was reported that a patient underwent a cholecystectomy procedure on (b)(6) 2024; and a suture was used.During the procedure, the ratchet would not hook, engage and close when used on cystic artery.Another like device was used to complete the procedure.There were no adverse consequences to the patient.No additional information was provided.
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Manufacturer Narrative
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Product complaint (b)(4) date sent to the fda: 6/3/2024 h6 component code: g07002 no device problem found additional information.H3 investigational summary: the product was returned to ethicon.Visual inspection and functional testing were conducted on the returned cartridge.Visual analysis of the returned sample revealed that the xc200 cartridge was not received, only one loose clip along with an opened foil were returned with no apparent damage.The clip was manually loaded and tested for functionality with a test device.Upon functional testing, the instrument loaded, retained and deployed the clip as intended.The clip was form as intended and conforming to our manufacturing requirements.As part of ethicon's quality process all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the clip performed without any difficulties noted.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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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Search Alerts/Recalls
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