SMITH & NEPHEW, INC. MOTOR DRIVE UNIT, HAND CNTRL, PWRMX EL; SAW, POWERED, AND ACCESSORIES
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Catalog Number 72200616 |
Device Problem
Partial Blockage (1065)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/23/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).No evaluation conducted to date, awaiting receipt of device.(b)(4).
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Event Description
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It was reported that during an acl procedure, the device presented repeated blockages in the lumen.The procedure was completed with a competitor's device.No patient injury or complications were reported.
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Manufacturer Narrative
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Device investigation narrative - the subject device, a powermax elite mdu, part number 72200616 with serial number (b)(4), was not made available to the designated complaint unit for evaluation and thus a visual and functional evaluation could not be performed nor could a root cause be determined with confidence.A review of the device history record was performed and shows this device met specification when released to distribution on or about august 20, 2012 and has been in service for approximately four years.Factors which could have contributed to the event include material blockage of the aspiration tube due to incomplete cleaning or corrosion.Please refer to the instruction for use regarding appropriate cleaning chemicals and procedures.No containment or corrective actions are recommended at this time.Should the device be returned, this investigation will be reopened.(b)(4).
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