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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
Catalog Number 72200873
Device Problem Mechanical Jam (2983)
Patient Problem No Patient Involvement (2645)
Event Date 04/30/2020
Event Type  malfunction  
Manufacturer Narrative
The sample is under evaluation by the manufacturing site.
 
Event Description
It was reported that the control unit was not turning on. No case involved. Preliminary results of investigation have concluded that this unit presented a handpiece stall error which makes it a reportable event. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
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Brand NameDII CONTROLLER
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 Key10457918
MDR Text Key204542319
Report Number1643264-2020-00976
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K062849
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 09/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72200873
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/22/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/05/2020
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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