COOK INC PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTOR; FFL DISLODGER, STONE, BASKET, URETERAL, METAL
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Catalog Number NTRSE-100038 |
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 06/08/2016 |
Event Type
malfunction
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Manufacturer Narrative
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This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
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Event Description
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It was reported that while performing a functional check of the device prior to patient contact, the physician noticed that the basket wire loops looked separated, and the basket had a collapsed or curled shape when opened.Visual examination noted that one of the formation wires had been cut.Another device was used to perform the procedure, and there were no injuries or additional procedures.
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