Catalog Number 7222120000 |
Device Problem
Biocompatibility (2886)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/02/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Eighteen events were reported for this quarter.Fifteen devices were received for evaluation; fifteen events were confirmed during testing.Nine devices were found to be affected by fractured housing.Five devices were found to have missing components.One device was found to have a swollen component.Three devices are available for evaluation but have not yet been received.This device is not repairable and was not returned to the user facility.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 18 malfunction events in which the device had a condition in which the non-sterile battery had the potential to be exposed to the surgical site.Thirteen events had no patient involvement; no patient impact.Three events had patient involvement; no patient impact.Two events had no known patient involvement; no known patient impact.
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Manufacturer Narrative
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This mdr report is part of the malfunction summary reporting program, exemption number (b)(4).One device was received for evaluation; 1 event was confirmed during testing.One device was found to be affected by fractured housing rails.This device is not repairable and was not returned to the user facility.Correction: 2 devices were expected for evaluation but were not received.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 18 malfunction events in which the device had a condition in which the non-sterile battery had the potential to be exposed to the surgical site.Thirteen events had no patient involvement; no patient impact.Three events had patient involvement; no patient impact.Two events had no known patient involvement; no known patient impact.
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Search Alerts/Recalls
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