BOSTON SCIENTIFIC - SPENCER OBTRYX II SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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Model Number M0068505110 |
Device Problem
Torn Material (3024)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/11/2018 |
Event Type
malfunction
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Manufacturer Narrative
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A visual examination of the returned device revealed that the that the leader loops are not cut on either sleeve.The mesh is stretched and broken which allowed it to unravel to where the leader loop is attached to the mesh within the sleeve.As a result, the mesh detached from the sleeve and leader loop prematurely, without cutting the leader.The delivery device revealed no damage.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 an obtryx ii system was used during an insertion of transobturator sling procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the sleeve detached from the mesh prior to cutting the suture (leader loop).The tape was then removed and the procedure was completed with another obtryx ii system.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.This event has been deemed reportable based on the investigation results: mesh torn.
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