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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REPL {} C/U {} S&N DYONICS 25 ARTHROSCOPE

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SMITH & NEPHEW, INC. SVCE REPL {} C/U {} S&N DYONICS 25 ARTHROSCOPE Back to Search Results
Model Number 7211010
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/12/2018
Event Type  malfunction  
Event Description
It was reported that the device was over running flow in the case. No significant delay or patient injury reported.
 
Manufacturer Narrative
The device was received for evaluation. There was no relationship found between the returned device and the reported incident. A visual inspection was performed on the product and no issue was observed. Complaint of over pressurization could not be reproduced. Product passed functional testing per factory test with no faults or errors. Product passed functional testing during 6 hour burn-in on wet station utilizing low and high pressure and flow settings. Raw and zero transducer readings were normal and well within specs during all functional tests. At no time during functional testing did pump over pressurize, fluctuate, or become intermittent. All functions perform as expected. Pressure and flow readings were normal throughout burn-in on wet station. The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.
 
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Brand NameSVCE REPL {} C/U {} S&N DYONICS 25
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
Manufacturer (Section G)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
Manufacturer Contact
jim gonzales
7000 west william cannon drive
austin, TX 78735
MDR Report Key7409915
MDR Text Key105165589
Report Number1643264-2018-00272
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K171794
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7211010
Device Catalogue Number7211010SR
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/16/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/24/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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