Model Number LF1737 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Date of initial report : 02/11/2016.The incident device has been received and is under evaluation.When the device evaluation is complete, a follow-up report will be submitted.
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Event Description
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The customer reported that the sealing function did not work well during a laparoscopic gastrectomy.
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Manufacturer Narrative
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(b)(4).The incident device was returned, evaluated and found to function within specification.The device was tested for activation and sealing function on simulated tissue with acceptable results.Additional testing was done by performing multiple seals of various sizes on porcine tissue and all seal cycles were completed satisfactorily.Covidien was unable to confirm the customer¿s report.
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Search Alerts/Recalls
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