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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DII CONTROLLER SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. DII CONTROLLER SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 72200873
Device Problem Protective Measures Problem (3015)
Patient Problem No Patient Involvement (2645)
Event Date 04/20/2020
Event Type  Malfunction  
Event Description

It was reported that the dell controller's shaver was not operating. Incident occurred before the procedure; therefore, there was no patient involvement. Preliminary results of investigation have concluded that a hand piece stall error message 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 DeviceSAW, POWERED, AND ACCESSORIES
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
william
austin, TX 78735
5123913905
MDR Report Key10216166
MDR Text Key197094523
Report Number1643264-2020-00445
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
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 07/08/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/30/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number72200873
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/06/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/07/2020
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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