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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
Catalog Number 7211010
Device Problem Image Display Error/Artifact (1304)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/22/2019
Event Type  malfunction  
Event Description
It was reported that during a shoulder scope surgery the sensor on the side was not working, it was having an error message.No delay or patient injury reported.No backup device was available.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
 
Manufacturer Narrative
H3,h6: 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 complaint history review found related failures.A relationship, if any, between the subject device and the reported event could not be determined.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.No containment or corrective actions are recommended at this time.
 
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Brand Name
CONTROL UNIT DYONICS 25
Type of Device
ARTHROSCOPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
MDR Report Key9490811
MDR Text Key175905530
Report Number1643264-2019-00891
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
PMA/PMN Number
K171794
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 01/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number7211010
Was Device Available for Evaluation? No
Date Manufacturer Received01/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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