A review of the manufacturing records for this device did not reveal any non-conformity.This medical device report is being resubmitted to the emdr system due to a connection error within the emdr system.The event was previously reported to the emdr portal and an acknowledgement 3 received, but the connection error prevented the emdr system from documenting the report.The report number in this report is the same number as the impacted report that has the connection issue.If information is provided in the future, a supplemental report will be issued.
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An atherectomy procedure was performed using a turbohawk ss-c device.It was reported that the handle/collar of the device said ¿sx-c¿, instead of ¿ss-c.The procedure was successfully completed.No injury to patient.The device was received for evaluation on january 28, 2016.It was observed that the handle/collar showed sx-c.However, the length of the device and the packaging matched with an ss-c device.The evaluation confirmed the reported event.
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