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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 04/08/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Upon completion of the investigation, a follow up report will be filed.
 
Event Description
It was reported by the sales rep, that during a revision of an unknown valve, that had been indwelling for 12 years, a certas plus programmable valve was used; however, it did not function. So, another was used and the procedure was successfully completely. No delay or adverse event was reported. Complaint product will be returned.
 
Manufacturer Narrative
The device has been returned for evalutation. Upon completion of the investigation, a follow-up report will be submitted.
 
Manufacturer Narrative
(b)(4). Upon completion of the investigation it was noted that the images were taken of the valve ¿as received¿. The position of the cam when valve was received was at setting 3. The valve was visually inspected: no defects were noted. The valve was hydrated. 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, only leaked from the needle holes 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 siphon guard was removed. The valve was then pressure tested, the valve passed the test. Review of the history device records confirmed the valve product code 82-8804pl, with lot 117785, conformed to the specifications when released to stock on the 20th february 2017. No root cause could be determined, as the problem reported by the customer could not be duplicated. 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
le locle CH 24 00
SZ CH 2400
Manufacturer Contact
james kenney
325 paramount drive
raynham, MA 02767
5088282726
MDR Report Key6536761
MDR Text Key74179351
Report Number1226348-2017-10294
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,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number82-8804PL
Device Lot Number117785
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/03/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/07/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/20/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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