ETHICON INC. GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY; DEVICE, THERMAL ABLATION, ENDOMETRIAL
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Catalog Number TC003 |
Device Problem
Balloon leak(s) (1052)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/05/2015 |
Event Type
malfunction
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Event Description
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It was reported that a patient underwent an endometrial thermal ablation procedure on (b)(6) 2015.During the procedure, at 90 seconds into the therapy phase, the pressure dropped.The physician removed the fluid that was inserted into the catheter balloon and nothing came out.The physician noted leaking and the catheter was removed from the uterus.The case was aborted.A hysteroscopy was done after the event occurred and there were no patient consequences.
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Manufacturer Narrative
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(b)(4): actual sample was returned for evaluation.Visual and functional inspections were performed.During the leak test, a pinhole was found in the balloon at zone d at 1.43¿ from the suture point.
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Manufacturer Narrative
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(b)(4).Conclusion: 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.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
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