Model Number M0068318170 |
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 03/06/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(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 with capio slim was used during a sacrospinous ligament fixation procedure on (b)(6) 2018.According to the complainant, the dart detached from the suture and was found inside the capio device.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.
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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 a sacrospinous ligament fixation procedure on (b)(6) 2018.According to the complainant, the dart detached from the suture and was found inside the capio device.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.
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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 with white stripe dilator is broken.The dart was returned with a small amount of suture attached to it.Visual analysis revealed no damage to the capio slim suture capturing device.Functional analysis revealed that the device functions as intended.A review of the device history record (dhr) indicated that the device met all material, assembly, and product specifications at the time of release to distribution.However, the investigation concluded that the most probable cause for this event is manufacturing process design because the design or validation of the manufacturing process was not sufficient to ensure the finished device met the intent of the design.An investigation concluded that the design of the carrier allows the fiber portion of the suture to interact with the sharp edge of the carrier, resulting in suture severing.The issue is under investigation and a correction has not yet been implemented.
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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 a sacrospinous ligament fixation procedure on (b)(6) 2018.According to the complainant, the dart detached from the suture and was found inside the capio device.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.
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Manufacturer Narrative
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The assigned complaint investigation conclusion code for this event is supplier manufacturing process design because the design or validation of a suppliers manufacturing process was not sufficient to ensure the finished device met the intent of the design.
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Search Alerts/Recalls
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