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 Known Impact Or Consequence To Patient (2692)
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Event Date 06/15/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The complainant indicated that the device is disposed and will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, 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 was used during an anterior ureterocele repair procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the mesh was in place but the physician felt it was too tight.The physician decided to loosen it, but one of the mesh arm on the patient's right side broke.The mesh was removed from the patient.It was also noticed that the plastic sleeve was difficult to remove from the mesh.The physician noted that it was probably because of the patient's anatomy.The procedure was completed with another uphold lite.There were no patient complications reported as a result of this event.
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Search Alerts/Recalls
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