COOK INC NCIRCLE TIPLESS STONE EXTRACTOR; FFL DISLODGER, STONE, BASKET, URETERAL, METAL
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Catalog Number NTSE-030115-UDH-MB |
Device Problems
Break (1069); Detachment Of Device Component (1104); Difficult to Open or Close (2921)
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Patient Problem
No Information (3190)
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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.Blank fields on this form that have not been previously submitted indicate the information is unknown or unavailable.
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Event Description
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The complainant reported that a ureteroscopy was performed, the complaint device would not open, and the end of the device was broken off.It was further noted that the basket formation had 4 cut (broken) wires.A new device (same type) was used to complete the procedure.
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Search Alerts/Recalls
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