Catalog Number 0250040111 |
Device Problem
Device Operates Differently Than Expected (2913)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 11/03/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.(b)(4).
|
|
Event Description
|
It was reported that the insulation had been compromised.
|
|
Manufacturer Narrative
|
Alleged failure: they are not passing the electrical safety check after 1-2.Reprocessing cycles.The failure identified in the investigation is consistent with the complaint record.The probable root causes could be user misuse, excessive force, normal wear, or improper sterilization methods.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.(b)(4).
|
|
Event Description
|
It was reported that the insulation had been compromised.
|
|
Search Alerts/Recalls
|