ETHICON ENDO-SURGERY, LLC. ENSEAL G2 CURVED JAW 35CM; ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
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Catalog Number NSLG2C35 |
Device Problems
Device Alarm System (1012); Difficult to Open or Close (2921)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/30/2023 |
Event Type
malfunction
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Event Description
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It was reported that during an unknown procedure it does not open the clamp correctly, as if they will stick.He tries to work with the tweezers and after 5 minutes, it stays completely stuck, and he takes out the tweezers and tries to open them and succeeds.Subsequently, they report that they no longer open again and a legend "replace product" appears on the console, to which another one is provided new caliper.There were no patient consequences.
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Manufacturer Narrative
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(b)(4).Date sent: 10/4/2023.D4 batch #: unknown.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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.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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Search Alerts/Recalls
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