BOSTON SCIENTIFIC - MARLBOROUGH UPHOLD¿ LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number M0068318170 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Problem of suture broken.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 procedure.According to the complainant, during the procedure, when using the capio device to throw the lead suture of the uphold through the sacrospinous ligament, the suture broke near the needle.The needle, with a small amount of suture attached, remained stuck in the capio suture capturing device.All other information is unknown.Should additional relevant details become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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