BOSTON SCIENTIFIC - MARLBOROUGH UPHOLD¿ LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number M0068318170 |
Device Problem
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 10/10/2017 |
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 was used during an implantation of uphold lite with capio device performed on (b)(6) 2017.According to the complainant, after deployment of the capio device, while pulling the arm through the sacrospinous ligament on the right side of the patient, the needle detached from the suture and was found in the capio cage.The procedure was completed with another uphold¿ lite.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 stable.
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Manufacturer Narrative
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Investigation results a visual examination of the returned uphold¿ lite revealed that the suture on the blue dilator was broken.The remainder of the suture with the dart was not returned.Analysis revealed that there was no damage to the capio slim suture capturing 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.A search of the complaint database confirmed that no similar complaints exist for the specified lot.
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Event Description
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It was reported to boston scientific corporation that an uphold¿ lite with capio slim was used during an implantation of uphold lite with capio device performed on (b)(6) 2017.According to the complainant, after deployment of the capio device, while pulling the arm through the sacrospinous ligament on the right side of the patient, the needle detached from the suture and was found in the capio cage.The procedure was completed with another uphold¿ lite.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 stable.
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