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 08/11/2017 |
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.(b)(4).The device has not been received for analysis.Upon receipt and 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 was used during an anterior prolapse repair procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the needle detached from the suture during placement.The detached piece remained inside the capio head.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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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.The suture on the blue with white stripe dilator is cut most likely to facilitate removal.Analysis also 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.
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Event Description
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It was reported to boston scientific corporation that an uphold¿ lite was used during an anterior prolapse repair procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the needle detached from the suture during placement.The detached piece remained inside the capio head.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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Search Alerts/Recalls
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