BOSTON SCIENTIFIC - MARLBOROUGH UPHOLD¿ LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number M0068318170 |
Device Problem
Retraction Problem (1536)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/23/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The exact age of the patient is unknown.However, it was reported the patient was over 18 years.Device component code is related to device problem code for the problem of carrier would not retract.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¿ lite was used during an anterior repair procedure performed on (b)(6) 2018 according to the complainant, during the procedure, the capio carrier was unable to retract on the second pass outside the patient.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 healthy.
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Search Alerts/Recalls
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