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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DII CONTROLLER; ARTHROSCOPE
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SMITH & NEPHEW, INC. DII CONTROLLER; ARTHROSCOPE Back to Search Results
Model Number 72200873
Device Problem Smoking (1585)
Patient Problem No Patient Involvement (2645)
Event Date 06/19/2020
Event Type  malfunction  
Event Description
It was reported that the dii controller started smoking.No case involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
 
Manufacturer Narrative
The reported device, intended for use in treatment, was received for evaluation.A visual inspection was performed on the product and no issue was observed.There was a relationship found between the returned device and the reported incident.Product failed functional testing with short circuit detected error and a burnt resistor on main pcb.Cause of failure is a defective electronic component.The complaint was confirmed and the root cause has been determined to be defective electronic component.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.
 
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Brand Name
DII CONTROLLER
Type of Device
ARTHROSCOPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107
MDR Report Key10280958
MDR Text Key199034823
Report Number1643264-2020-00579
Device Sequence Number1
Product Code HRX
UDI-Device Identifier03596010607409
UDI-Public03596010607409
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
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 08/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number72200873
Device Catalogue Number72200873
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/29/2020
Date Manufacturer Received08/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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