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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 Device Operational Issue (2914)
Patient Problem No Information (3190)
Event Date 11/09/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Upon completion of the investigation a follow up report will be filed.
 
Event Description
Certas valve was not working. Dr. Was not sure why. Original date of implant was (b)(6) 2016 and patient was doing well. She began to crash and they revised her on (b)(6) 2016.
 
Manufacturer Narrative
Device was returned for evaluation. A follow up report will be filed upon completion of the investigation.
 
Manufacturer Narrative
Device evaluation: date received by mfr, type of reports, if follow-up, what type?, device evaluated by mfr?, evaluation codes, additional mfr narrative. Upon completion of the investigation it was noted that the position of the cam when valve was received was at setting 3. The valve was visually inspected: a needle hole in the needle chamber was noted. 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 was leak tested, leaked from the needle hole in the needle chamber. The valve was reflux tested, the valve passed the test. The siphon guard was tested. The valve passed the test. The valve was dried. The valve was then pressure tested, the valve failed the test. The valve was dismantled and was examined under microscope at appropriate magnification: biological debris was found on the ruby ball, this debris was probably stopping the ruby ball from sitting correctly on the seat of the ruby ball. Review of the history device records confirmed the valve product code 82-8805pl, with lot ctmb87, conformed to the specifications when released to stock in 3rd november 2015. The root cause for the pressure problem found during investigation was due to biological debris on the ruby ball. 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 case postale
le locle
SZ
Manufacturer Contact
james kenney
325 paramount drive
raynham, MA 02767
5088282726
MDR Report Key6138720
MDR Text Key61234092
Report Number1226348-2016-10824
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 health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2016
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 Manufacturer12/07/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/17/2017
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: 12/01/2016 Patient Sequence Number: 1
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