BOSTON SCIENTIFIC - SPENCER 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 04/18/2018 |
Event Type
malfunction
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Manufacturer Narrative
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A visual examination of the returned solyx sis system revealed that there was no damage to the mesh assembly.The carriers could load onto and deploy from the delivery device as intended.Analysis revealed that the tip of the delivery device was slightly bent indicating that the user had difficulty during placement.Functional analysis revealed that the device functioned as intended.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 solyx sis system was used during a sling incision for incontinence procedure performed on (b)(6) 2018.According to the complainant, during the procedure, it was difficult for the shaft tip or the mesh carrier of the solyx device to pierce the obturator muscle.The procedure was completed with an obtryx halo device.The patient's condition at the conclusion of the procedure was reported to be stable.This event has been deemed reportable based on the investigation results: the tip of the delivery device was slightly bent.
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