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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CONTROL UNIT DYONICS 25 ARTHROSCOPE

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SMITH & NEPHEW, INC. CONTROL UNIT DYONICS 25 ARTHROSCOPE Back to Search Results
Catalog Number 7211010
Device Problems Increase in Pressure (1491); Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/27/2018
Event Type  malfunction  
Event Description
It was reported that during a shoulder procedure, the device was over pressurizing. A backup device was available to complete the procedure with no significant delay and no patient injuries. Patient outcome is good.
 
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. A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.
 
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Brand NameCONTROL UNIT 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
5123585706
MDR Report Key8206042
MDR Text Key131763493
Report Number1643264-2018-01014
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 health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/18/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number7211010
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/17/2019
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 Unkown

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