BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
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Model Number M0068507000 |
Device Problem
Premature Activation (1484)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/28/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(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 a solyx sis system was used during a procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the mesh came unattached from the device.This event most likely suggests that the mesh carrier unintentionally released from the shaft assembly.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
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Search Alerts/Recalls
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