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 03/17/2014 |
Event Type
malfunction
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Event Description
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It was reported that a patient underwent a hysterectomy on (b)(6) 2014.During the procedure, the blade locked and did not expose and rotate preventing morcellation.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).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 rotated and exposed as the device operated as intended.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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Search Alerts/Recalls
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