BOSTON SCIENTIFIC CORPORATION UPHOLD LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number M0068318170 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/25/2018 |
Event Type
Injury
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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 was used during an anterior vaginal repair procedure performed on (b)(6) 2018.According to the complainant, during procedure, the capio device was fired five times, and on the fifth time, it broke inside the patient.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 carrier broke.The procedure was completed with a another uphold (tm) lite with capio slim.There were no patient complications reported as a result of this event.The patient was reported to be fine.
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Search Alerts/Recalls
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