COOK INC PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTOR; FFL DISLODGER, STONE, BASKET, URETERAL, METAL
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Catalog Number NTRSE-100038 |
Device Problems
Break (1069); Material Discolored (1170); Structural Problem (2506)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/24/2016 |
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 after removing some stone fragments, the basket was no longer opening or closing.The procedure was completed by using another device.The device was returned and examined, and it was found to have a broken basket wire and some black and blue discoloration.There were no injuries or additional procedures.
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Search Alerts/Recalls
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