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 01/29/2018 |
Event Type
Injury
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Manufacturer Narrative
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Initial reporter can also be reached at (b)(6).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 (tm) lite w/ capio slim was used during a sacrospinous ligament fixation procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the dart detached from the suture after it was deployed through the ligament.The procedure was completed with another uphold (tm) lite w/ capio slim.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 (tm) lite w/capio slim revealed that the suture on the blue dilator was broken off at the distal end of the dilator.The dilator was torn at the distal end.The suture with dart was returned.Visual analysis also revealed no damage to the capio slim suture capturing device.Functional analysis revealed that the device functioned as intended.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 (tm) lite w/capio slim was used during a sacrospinous ligament fixation procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the dart detached from the suture after it was deployed through the ligament.The procedure was completed with another uphold (tm) lite w/capio slim.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.
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