BOSTON SCIENTIFIC - MARLBOROUGH SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
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Model Number M0068507000 |
Device Problem
Positioning Failure (1158)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/30/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The exact age of the patient is unknown, however, it was reported the patient was over 18 years.A visual examination of the returned solyx sis system revealed that one the mesh was stretched on one end near the carrier.The pusher tube is buckled at the distal end.Both carriers release from the delivery device.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 mid urethral sling placement procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the mesh carrier was unable to release from the shaft tip.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.
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