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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DII CONTROLLER ARTHROSCOPE

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SMITH & NEPHEW, INC. DII CONTROLLER ARTHROSCOPE Back to Search Results
Catalog Number 7211010
Device Problem Pressure Problem (3012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/29/2019
Event Type  malfunction  
Event Description
It was reported that, during a knee arthroscopy, the controller just kept pumping, causing an over-pressure; tubing out was necessary to stop it. A back-up device was readily available to successfully complete the procedure. Neither significant delay nor patient injuries occurred as a consequence of the alleged malfunction.
 
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 NameDII CONTROLLER
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 Key8353947
MDR Text Key137035441
Report Number1643264-2019-00123
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062849
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 03/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/20/2019
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 Manufacturer03/08/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/20/2019
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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