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Model Number M0068318261 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/13/2018 |
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 a capio¿ slim device was used during an anterior/posterior vaginal prolapse repair procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the dart from the capio suture broke off while the suture was being pulled through the right sacrospinous ligament.Reportedly, the detached dart was caught in the capio cage.The procedure was completed with another capio¿ slim.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.
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Manufacturer Narrative
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An examination of the returned device revealed that the carrier does not have any visual failure.The carrier was actuated three times and it extended and retracted without any issues.Also, it was actuated (deployed) three times with the suture and the needle entered in the slot without any issues.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.Based on all gathered information and investigation results, there is no evidence of the alleged issue.Therefore the most probable cause for the complaint is not confirmed-returned.
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Event Description
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It was reported to boston scientific corporation that a capio¿ slim device was used during an anterior/posterior vaginal prolapse repair procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the dart from the capio suture broke off while the suture was being pulled through the right sacrospinous ligament.Reportedly, the detached dart was caught in the capio cage.The procedure was completed with another capio¿ slim.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.
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Search Alerts/Recalls
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