BOSTON SCIENTIFIC - MARLBOROUGH SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
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Model Number M0068507000 |
Device Problem
Bent (1059)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/04/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).A visual examination of the returned solyx sis system revealed that the barbed delivery device tip was slightly bent and the mesh assembly was stretched on both ends.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.The investigation concluded that this complaint is associated with a product that meets the design and manufacture specifications but due to anatomical/procedural factors encountered during the procedure, performance of the device was limited.The most probable root cause classification is operational context.
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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 sling placement procedure on (b)(6) 2016.According to the complainant, during the procedure, the mesh was damaged during insertion.The procedure was completed with another solyx sis system.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.This event has been deemed reportable based on the investigation finding: delivery device tip bent.
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