BOSTON SCIENTIFIC - MARLBOROUGH UPHOLD¿ LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number M0068318170 |
Device Problem
Material Separation (1562)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/09/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Mfg site name - (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 mdr will be filed.
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Event Description
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It was reported to boston scientific corporation that a uphold¿ lite device was about to be used in a sacrospinous ligament fixation procedure on (b)(6), 2017.According to the complainant, during unpacking of the device, it was found that the mesh split into two parts when the whole package of device was opened.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 blue with white stripe dilator was torn at the distal end.A part of the dilator including the suture with dart was missing and was not returned.There was no damage to the mesh.Analysis also 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 undeterminable.A complaint with a cause classification of undeterminable indicates review and analysis of all available information fails to indicate a cause or probable cause.
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Event Description
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It was reported to boston scientific corporation that a uphold¿ lite device was about to be used in a sacrospinous ligament fixation procedure on (b)(6) 2017.According to the complainant, during unpacking of the device, it was found that the mesh split into two parts when the whole package of device was opened.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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