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 03/14/2014 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The actual device involved in this event was returned for evaluation.The device was visually and functionally evaluated.Upon evaluation, the device operated as intended.In addition, a review of the device manufacturing records was conducted and the device met all finished goods release criteria.
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Event Description
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It was reported that the patient underwent a laparoscopic myomectomy on (b)(6) 2014.During the removal of myoma, the blade did not rotate properly.Another like device was used to complete the procedure.No adverse patient consequences reported.
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Manufacturer Narrative
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(b)(4) - poor blade performance.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.
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Search Alerts/Recalls
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