Model Number EL-1515S2 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/06/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Patient information is not available for reporting.Device is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that the inserter was stuck while inserting a bme elite implant during an unknown procedure on (b)(6) 2018.It will not release, so the staple came out and could not be implanted due to the issue with the inserter.There was a five (5) minute surgical delay and procedure was successfully completed.Patient outcome was good.This report is for one (1) elite compression implant kit 15x15x15mm 2 legs.This is report 1 of 1 for complaint (b)(4).
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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The procedure performed was a foot surgery.Another staple was used to complete the procedure.
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Search Alerts/Recalls
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