BOSTON SCIENTIFIC - MARLBOROUGH UPHOLD¿ LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number M0068318170 |
Device Problem
Retraction Problem (1536)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/10/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation that an uphold¿ lite with capio slim device was used during a pelvic floor repair procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the capio cage failed to catch the needle.After several attempts, the carrier cracked and failed to retract.The procedure was completed with another uphold¿ lite with capio slim device.The patient's condition at the conclusion of the procedure was reported to be stable.
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Manufacturer Narrative
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A visual examination of the returned uphold¿ lite with capio slim revealed that the capio slim head was split at the seam of the proximal end.As a result, the head was not secured at the proximal end allowing the head to spin, which would cause the cage to fail to catch needle during use.All rivets were attached.Analysis revealed no damage to the uphold lite mesh assembly.Functional analysis showed that the carrier retracted as intended and the carrier was not broken.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 uphold¿ lite with capio slim device was used during a pelvic floor repair procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the capio cage failed to catch the needle.After several attempts, the carrier cracked and failed to retract.The procedure was completed with another uphold¿ lite with capio slim device.The patient's condition at the conclusion of the procedure was reported to be stable.
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