Model Number LF2019 |
Device Problem
Energy Output Problem (1431)
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Patient Problems
Blood Loss (2597); No Code Available (3191)
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Event Date 01/19/2020 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, after the procedure, there was a bleeding even though an end tone was observed from the device.
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Manufacturer Narrative
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Evaluation summary: one device was received for evaluation.The returned product met specification as received.Visual inspection found no defects.The reported condition was not confirmed.Functional testing was performed with the returned devices on porcine kidney tissue.Multiple seals on various size vessels were made with visually acceptable results.All seal cycles were completed satisfactory and end tones were heard indicating completed activation cycles.The investigation found the device to function normally and within specifications.Refer to the product instructions for use for recommendations on tissue sealing.The instructions for use (ifu) states, keep the instrument jaws clean.Build-up of eschar may reduce the seal and / or cutting effectiveness.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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(b)(4).If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, during procedure, there was a bleeding even though an end tone was observed from the device.They used another device to stop the bleeding.
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Search Alerts/Recalls
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