|
Catalog Number EMAX2PLUS |
Device Problem
Device Inoperable (1663)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 03/12/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
The actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.
|
|
Event Description
|
This is event 1 of 3 of the same event.It was reported from (b)(6) that during an unspecified surgical procedure, it was observed that the motor device did not work even after the foot switch was stepped on while in use with the console device.It was unknown if there were delays to the surgical procedure or if a spare device was available for use.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
|
|
Manufacturer Narrative
|
This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the device hose had a cut/hole.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use and servicing.If additional information should become available, a supplemental medwatch will be submitted accordingly.
|
|
Search Alerts/Recalls
|
|
|