Model Number CTS02 |
Device Problems
Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/29/2014 |
Event Type
malfunction
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Event Description
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It was reported that there is an unknown substance inside of the packaging.There was no patient involvement.There was no medical treatment or intervention and no adverse consequences associated with this event.
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Manufacturer Narrative
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An investigation has not yet been completed for this event.A supplemental will be submitted once the investigation is complete.
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Manufacturer Narrative
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The complaint device was not returned to stryker sustainability solutions (sss) for an evaluation.The device was not returned with the open packaging.The device packaging was returned and was not clean and had debris.Spots were located throughout the packaging, however, no wet areas were noted.Although the device was not returned, the results of the visual inspection of the packaging determined that the reported event was not confirmed.A review of the dhr supports that the device is unlikely to have been released from stryker with the reported failure mode.The reported event could be attributed to: hazing/blooming present on device and/or excessive adhesive/lubricant on device.The device history record (dhr) was reviewed to confirm the device met all inspection and testing requirements prior to distribution.The reported event will continue to be monitored through post-market surveillance.Device not returned.
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Event Description
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It was reported that there is an unknown substance inside of the packaging.There was no patient involvement.There was no medical treatment or intervention and no adverse consequences associated with this event.
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Search Alerts/Recalls
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