Catalog Number 5400702000 |
Device Problem
Delivered as Unsterile Product (1421)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 06/02/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
This mdr report is part of the malfunction summary reporting program, exemption number e2015055.Reported events: 4 events were reported for this quarter.Product return status: 3 devices were available for evaluation but have not yet been received.1 device was not available to stryker for evaluation.Additional information: 4 devices are labeled for single-use.4 devices were not reprocessed and reused.
|
|
Event Description
|
This report summarizes 4 malfunction events in which the device had a white substance or dust in the packaging.4 events had patient involvement; no patient impact.
|
|
Manufacturer Narrative
|
This mdr report is part of the malfunction summary reporting program, exemption number e2015055.Supplemental rationale corrected data: 4 total events were initially reported.3 previously reported events are included in this follow-up record. product return status 3 devices were received. evaluation status confirmed 3 reported events were confirmed during testing.- devices were found to be affected by excessive vibration/shaking during shipping and handling. additional information 4 devices were labeled for single-use.4 devices were not reprocessed and reused.
|
|
Event Description
|
This report summarizes 4 malfunction events in which the device had a white substance or dust in the packaging.4 events had patient involvement; no patient impact.
|
|
Search Alerts/Recalls
|