Catalog Number 0250181106 |
Device Problem
Crack (1135)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 11/14/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).The device manufacture date is not known at this time.Additional information will be provided once the investigation has been completed.
|
|
Event Description
|
It was reported the insulation is cracked.
|
|
Manufacturer Narrative
|
(b)(4).The device manufacture date is not known.Alleged failure: failed insulscan.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be normal wear, user misuse, and improper sterilization methods.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.
|
|
Event Description
|
It was reported the insulation is cracked.
|
|
Search Alerts/Recalls
|