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 Consequences Or Impact To Patient (2199)
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Event Date 02/07/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The complaint device is not expected to 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 (tm) lite w/ capio slim device was used during a colpopexy via vaginal procedure on (b)(6) 2018.According to the complainant, during the procedure, when the physician was trying to mount the suture of an uphold mesh in the capio device, the carrier broke.The procedure was completed with another uphold (tm) lite w/ capio slim.There were no complications reported as a result of this event.The condition of the patient was reported to be stable.
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Search Alerts/Recalls
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