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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. CERTAS PLUS INLINE WITH SIPHONGUARD VALVE ONLY SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

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CODMAN & SHURTLEFF, INC. / MEDOS S.A. CERTAS PLUS INLINE WITH SIPHONGUARD VALVE ONLY SHUNT, CENTRAL NERVOUS SYSTEM & COMPS Back to Search Results
Catalog Number 82-8804PL
Device Problem Break (1069)
Patient Problem Swelling (2091)
Event Date 09/02/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Upon completion of the investigation a follow up report will be filed.
 
Event Description
Patient visited clinic on (b)(6) observed swelling around valve site. Patient admitted for surgery on (b)(6) and operated to revise shunt. Observed broken siphonguard. And replaced valve. Replaced valve with new certas plus. No delays.
 
Manufacturer Narrative
Upon completion of the investigation it was noted that the position of the cam when valve was received was at setting 8. The valve was visually inspected: confirms the broken silicone housing and the siphon guard no longer attached to the valve, clamp marks were noted on the hard plastic of the siphon guard. The valve was hydrated for 24 hours. The valve was tested for programming. The valve passed the test. The valve was flushed, the valve passed the test no occlusion was noted. The valve could not be leak tested due to the damage silicone housing. The valve could not be reflux tested due to the damage silicone housing. The valve was dried. The valve was then pressure tested, the valve passed the test. Review of the history device records was not possible as the lot number is unknown. The root cause for the damaged silicone housing is probably due to user¿s error when using clamps/forceps, this however could not be determined. Based on the results of this investigation no further action is required. Trends will be monitored for this and similar complaints. At the present time this complaint is closed.
 
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Brand NameCERTAS PLUS INLINE WITH SIPHONGUARD VALVE ONLY
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM & COMPS
Manufacturer (Section D)
CODMAN & SHURTLEFF, INC. / MEDOS S.A.
rue girardet 29
ch-2400 le locle
SZ
Manufacturer Contact
james kenney
325 paramount drive
raynham, MA 02767
5088282726
MDR Report Key5963882
MDR Text Key55164888
Report Number1226348-2016-10677
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143111
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number82-8804PL
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/14/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/12/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/20/2016 Patient Sequence Number: 1
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