BOSTON SCIENTIFIC - MARLBOROUGH UPHOLD¿ LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number M0068318170 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/07/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation that an uphold lite with capio slim was used during an anterior repair procedure performed on (b)(6) 2018.According to the complainant, during the procedure and during the deployment of the mesh, the dart detached from the suture and was found in the capio cage.The procedure was completed with another uphold lite with capio slim.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
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