CODMAN & SHURTLEFF, INC. / MEDOS S.A. HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
|
Back to Search Results |
|
Catalog Number 82-3100 |
Device Problem
Device Dislodged or Dislocated (2923)
|
Patient Problem
No Information (3190)
|
Event Date 11/10/2017 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4) upon completion of the investigation, a follow up report will be filed.
|
|
Event Description
|
As reported by the (b)(6), a hakim programmable valve malfunctioned.There were no reports of delay or patient harm.More information will be requested.
|
|
Manufacturer Narrative
|
The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.
|
|
Manufacturer Narrative
|
Updated udi : (b)(4).The valve was returned for evaluation.The device was visually inspected; it was noted that the stator was dislodged as well as a crack in the valve casing.Due to the condition of the device as it was returned, the cam position/pressure could not be determined.-the valve was dismantled and was examined under microscope at appropriate magnification.A crack was found in the valve casing.This is likely due to the valve receiving a hard knock.Corrosion was also noted on the stator.The cam magnets were controlled and passed testing.Review of the history device records confirmed the valve conformed to the specifications when released to stock.Based on the results of the investigation, the reported issue was confirmed.The root causes for the dislodged stator could be partly due to the valve receiving a hard knock.The root cause of the corrosion could not be clearly determined.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.
|
|
Search Alerts/Recalls
|
|
|