STRYKER INSTRUMENTS-KALAMAZOO ES6 STERNUM SAW; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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Catalog Number 6297000000 |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/02/2016 |
Event Type
malfunction
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Manufacturer Narrative
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This mdr report is part of the 227 pilot program, exemption number (b)(4).Two devices were received for evaluation; 2 events were confirmed during testing.Two devices were found to be affected by an electrical problem.There were no remedial actions taken.This device is not labeled for single-use.
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Event Description
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This report summarizes 2 malfunction events in which the device displayed a bias current error message on the console, signaling a condition occurred in which the device has the potential to run without user activation.There was no patient involvement; no patient impact.
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Search Alerts/Recalls
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