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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. RFB CONTROL UNIT DYONICS 25 ARTHROSCOPE Back to Search Results
Catalog Number 7211010F
Device Problem Pressure Problem (3012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
It was reported that during a procedure, the device was not maintaining the pressure; however, the joint was over pressurized. Procedure was completed with the same device. No delay nor patient injuries were reported.
 
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Brand NameRFB CONTROL 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 w william cannon drive
austin, TX 78735
5123585706
MDR Report Key8619488
MDR Text Key145487967
Report Number1643264-2019-00355
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051326
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/14/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number7211010F
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/03/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/13/2019
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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