COLOPLAST A/S ALTIS SINGLE INCISION SLING SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYN, STRESS URINARY INCONT, FEMALE
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Model Number 519650 |
Device Problems
Break (1069); Material Separation (1562)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 12/30/2020 |
Event Type
malfunction
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Event Description
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During insertion of the altis sling, one tip of the applicator broke off during attachment of sling to bone.A second applicator was opened, and used.Patient was taken to pacu where x-ray was taken.Per physician, one tip was located on x-ray near the pelvic bone.It was determined that removing this tip would cause more harm then leaving it in.Patient did not experience any adverse effects and was discharged home as planned.
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