COOK INC NCIRCLE TIPLESS STONE EXTRACTOR; FFL DISLODGER, STONE, BASKET, URETERAL, METAL
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Catalog Number NTSE-022115-UDH |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/30/2015 |
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), compliant/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 a stone extraction procedure, the arm of the basket broke.Another device was used to complete the procedure with no harm to the patient.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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