STRYKER INSTRUMENTS-KALAMAZOO SYS 6 RECIP; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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Catalog Number 6206000000 |
Device Problem
Sticking (1597)
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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.One device was found to be affected by trigger damage.One device was found to have a contaminated trigger.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 safety of the device was stuck, presenting a condition in which the device could be inadvertently activated.There was no patient involvement; no patient impact.
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Search Alerts/Recalls
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