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Catalog Number AE-428115 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/20/2014 |
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 cysto holmium laser stone removal procedure, a piece of the basket came off.The piece did not detach inside the patient and another device was used to complete the procedure.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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