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 Consequences Or Impact To Patient (2199)
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Event Date 08/30/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The complainant indicated that the device was disposed of 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 single incision sling was used during a solyx sis (single incision sling) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the physician was trying to loosen / adjust the positioning when the mesh carrier unintentionally released from the shaft assembly inside the patient.The procedure was completed with a different device.There were no patient complications as a result of the event.The patient's condition at the conclusion of the procedure was reported to be stable.
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Search Alerts/Recalls
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