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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 Protective Measures Problem (3015)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/04/2021
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference (b)(4).
 
Event Description
It was reported that the motor drive unit had a handpiece sensor fault seen on the display, with a functional mdu. No case was involved.
 
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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 Key11859834
MDR Text Key252240388
Report Number1643264-2021-01924
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K062849
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72200873
Device Catalogue Number72200873
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/16/2021
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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