BOSTON SCIENTIFIC - SPENCER UPHOLD¿ LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number M0068318170 |
Device Problem
Retraction Problem (1536)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/03/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, 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 was used during a pelvic floor repair procedure performed on (b)(6) 2018.According to the complainant, the part of the delivery system which helps ¿picking¿ the mesh was not functional.Thus, it was not possible to implant the mesh with the device.The failure mode is unclear, and attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.The event description may suggest that the needle carrier was unable to retract.
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Search Alerts/Recalls
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