Catalog Number MX0100 |
Device Problem
Other (for use when an appropriate device code cannot be identified) (2203)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/02/2014 |
Event Type
malfunction
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Event Description
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It was reported that a patient underwent a laparoscopic hysterectomy on (b)(6) 2014.During the procedure, the blade did not rotate after the device was activated twice without a problem.Another like device was used to complete the procedure with no adverse patient consequences.
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Manufacturer Narrative
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(b)(4) - blade seized/stopped.Conclusion: to date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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Manufacturer Narrative
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Conclusion: the actual device involved in this event was returned for evaluation.The device was visually and functionally evaluated.Upon evaluation, the blade failed to rotate.It is likely that the accumulation of blood, body fluids, and tissue prevented the device from continuing to operate as intended.
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Search Alerts/Recalls
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