Catalog Number 0250080618 |
Device Problem
Crack (1135)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 02/03/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
Additional information will be provided once the investigation has been completed.The device manufacture date is not known at this time.However, should it become available, it will be provided in future reports.
|
|
Event Description
|
It was reported the insulation on the shaft was cracked.
|
|
Manufacturer Narrative
|
The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.The handle was visually inspected for damages, and the insulation has deep scratches and dents.Also, the insulation appears faded.The instrument passed the insul scan test.The probable root causes could be normal wear, improper sterilization methods or user misuse.(b)(4).
|
|
Event Description
|
It was reported the insulation on the shaft was cracked.
|
|
Search Alerts/Recalls
|