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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
Model Number 7211010F
Device Problem Pressure Problem (3012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/10/2021
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference (b)(4).
 
Event Description
It was reported that during a shoulder procedure, the dyonics control unit infused more liquid than usual to the shoulder's patient.It is unknown how the procedure was finished.No delay and no patient injuries were reported.
 
Manufacturer Narrative
The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.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.A relationship, if any, between the subject device and the reported event could not be determined.No containment or corrective actions are recommended at this time.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.A complaint history review concluded this was a repeat issue.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
 
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Brand Name
RFB CONTROL UNIT DYONICS 25
Type of Device
ARTHROSCOPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107
MDR Report Key12456355
MDR Text Key270922836
Report Number1643264-2021-02285
Device Sequence Number1
Product Code HRX
UDI-Device Identifier03596010643827
UDI-Public03596010643827
Combination Product (y/n)N
PMA/PMN Number
K051326
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number7211010F
Device Catalogue Number7211010F
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 08/11/2021
Initial Date FDA Received09/10/2021
Supplement Dates Manufacturer Received09/30/2021
Supplement Dates FDA Received10/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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