BOSTON SCIENTIFIC - MARLBOROUGH UPHOLD¿ LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number M0068318170 |
Device Problem
Misfire (2532)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/05/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Mfg.Site name - freudenberg medical.The complainant indicated that the device was contaminated 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 a pelvic floor repair procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the capio device misfired.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.
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