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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
Model Number 7211010
Device Problem Increase in Pressure (1491)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/07/1901
Event Type  malfunction  
Event Description
It was reported that during a shoulder procedure, the control unit, dyonics 25 was giving a pressure output higher than what was set. It is unknown how the procedure was completed. No delay nor patient complications were reported.
 
Manufacturer Narrative
Internal complaint reference case-(b)(4).
 
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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
Manufacturer (Section G)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key13088070
MDR Text Key282782293
Report Number1643264-2021-02494
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 Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7211010
Device Catalogue Number7211010
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/10/2021
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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