ETHICON INC. GYNECARE TVT ABREVO CONTINENCE SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
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Catalog Number TVTOML |
Device Problem
Break (1069)
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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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Manufacturer Narrative
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Conclusion: the actual device involved in this event was returned for evaluation.The device was visually evaluated.Upon evaluation, one needle was bent and broken at two sites on its middle, not at the tip.Based on the product evaluation performed, it seems that when using the device, the helical passer has been removed and reintroduced in the needle creating the bent on the middle of the plastic needle.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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Event Description
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It was reported that a patient underwent a sling procedure on (b)(6) 2014.During the procedure, the device had a broken trocar sheath tip upon opening.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).The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
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Search Alerts/Recalls
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