BOSTON SCIENTIFIC - MARLBOROUGH UPHOLD¿ LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number M0068318170 |
Device Problems
Break (1069); Detachment Of Device Component (1104)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/02/2017 |
Event Type
Injury
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Manufacturer Narrative
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Device component code is related to device problem code for the problem of carrier detachment.Device component code is related to device problem code for the problem of lead suture broke.Analysis of the returned device revealed that the blue dilator is broken.The remainder of the suture with dart was not returned.The suture on the blue with white stripe dilator is broken.The remainder of the suture with dart was not returned.Analysis also revealed that part of the carrier on the capio slim suture capturing device is broken off and was not returned.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.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
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Event Description
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It was reported to boston scientific corporation that an uphold¿ lite device was used during a vaginal prolapse repair procedure performed on (b)(6) 2017.According to the complainant, during procedure, the carrier failed to extend.The procedure was completed with a different device.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 results: the blue dilator is broken.The remainder of the suture with dart was not returned.The suture on the blue with white stripe dilator is broken.The remainder of the suture with dart is missing and was not returned.Analysis also revealed that part of the capio carrier is broken off and was not returned.
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Search Alerts/Recalls
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