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
Device Embedded In Tissue or Plaque (3165)
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Event Date 11/30/2016 |
Event Type
Injury
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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 an uphold (tm) lite w/ capio slim was used during sacrospinous ligament fixation procedure on (b)(6) 2016.According to the complainant, during the procedure, the needle detached while implanting the first leg.It was too small to be removed and was left inside the patient.The procedure was completed with another uphold (tm) lite w/ 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 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 is broken.There is frayed suture remaining at the break.The suture and dart are missing and were not returned.Also, the 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 (tm) lite w/ capio slim was used during sacrospinous ligament fixation procedure on (b)(6) 2016.According to the complainant, during the procedure, the needle detached while implanting the first leg.It was too small to be removed and was left inside the patient.The procedure was completed with another uphold (tm) lite w/ 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 stable.
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