BOSTON SCIENTIFIC CORPORATION 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 Consequences Or Impact To Patient (2199)
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Event Date 10/16/2018 |
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 lite with capio slim device was used during an anterior repair with mesh and ureteral sling procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the capio carrier would not retract during the first deployment of the device.The account opened another uphold lite with capio slim device.However, it is unknown if the mesh assembly from the second kit was also used.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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Search Alerts/Recalls
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