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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 Protective Measures Problem (3015)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/19/2021
Event Type  Injury  
Manufacturer Narrative
Internal complaint reference case-(b)(4).
 
Event Description
It was reported that during the surgery when the control unit cassette was entered it gave an error, , "wrong/no instrument. Staff proceeded to remove the cassette, and shut off the device, restart the device and re insert the cassette. The error code no longer appeared. The procedure started. During the procedure it was noticed at the irrigation bag an excess amount of fluid was being utilized. The surgeon noted firmness in the patient's thigh. The flow was change to low. The irrigation fluid bag pole was raise to the highest level so the surgery could be completed using gravity. No other complications reported. Unknown if there was a delay. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
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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 Key11727027
MDR Text Key247502847
Report Number1643264-2021-01549
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 05/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7211010
Device Catalogue Number7211010
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/09/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/13/2021
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

Patient Treatment Data
Date Received: 04/26/2021 Patient Sequence Number: 1
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