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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 Mechanical Jam (2983)
Patient Problem No Information (3190)
Event Date 07/17/2020
Event Type  malfunction  
Event Description
It was reported that the controller had failure and unable to drive handle. Picture confirms a blade stall error. It is unknown if a delay happened, when was discovered the issue and if a backup device was available. However, no patient injuries were reported. 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 Key10383163
MDR Text Key202204090
Report Number1643264-2020-00800
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeKT
PMA/PMN Number
K062849
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/01/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72200873
Device Catalogue Number72200873
Device Lot NumberAAX35220
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2020
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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