COOK INC PERC NCIRCLE NITINOL TIPLESS STONE EXTRACTOR; FFL DISLODGER, STONE, BASKET, URETERAL, METAL
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Catalog Number NTRSE-120038 |
Device Problem
Difficult to Open or Close (2921)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/30/2016 |
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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During the procedure, the baskets did not open when pushing the handles.In addition, a visual examination noted that the basket formation has two wires cut and part of the basket formation wires appear to be missing.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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Search Alerts/Recalls
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