BOSTON SCIENTIFIC - SPENCER 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 Type
Injury
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Manufacturer Narrative
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Device component code is related to device problem code for the problem of needle detachment.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 pelvic floor repair procedure performed on an unknown date.According to the complainant, during the procedure, the dart detached from the suture after deployment of the "prosthesis leg." the procedure was completed with another uphold¿ lite with capio slim.There were no patient complications reported as a result of this event.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 with capio slim revealed that the distal end of the blue dilator was bunched up and the dart did not detach from the suture.The suture on the dilator was cut.The remainder of the suture with dart attached was returned.The suture was most likely cut to facilitate removal of the device.There was no damage to the blue with white stripe dilator.Analysis revealed 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 labeling review was performed and, from the information available, this device was used per the directions for use (dfu)/product label.
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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 pelvic floor repair procedure performed on an unknown date.According to the complainant, during the procedure, the dart detached from the suture after deployment of the "prosthesis leg." the procedure was completed with another uphold lite with capio slim.There were no patient complications reported as a result of this event.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.
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Search Alerts/Recalls
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