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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS BLADE,3.5MM,DISP SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. FULL RADIUS BLADE,3.5MM,DISP SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 7205305
Device Problem Corroded (1131)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/04/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(6). (b)(4).
 
Event Description
It was reported that during an unknown procedure that the shaver blade was seen to be rusty through the scope. There was no report of patient injury.
 
Manufacturer Narrative
Evaluation of the returned blades showed tarnishing on the inner blade. The appearance of the "tarnish" and discoloration does not have any adverse effect on the performance of the device, procedure or patient. The tarnishing discoloration is a cosmetic issue only. A review of the device history record was performed which confirmed no inconsistencies.
 
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Brand NameFULL RADIUS BLADE,3.5MM,DISP
Type of DeviceSAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
130 forbes boulevard
mansfield MA 02048
Manufacturer (Section G)
SMITH & NEPHEW, INC.
130 forbes boulevard
mansfield MA 02048
Manufacturer Contact
james gonzales
150 minuteman road
andover, MA 01810
5123585706
MDR Report Key5455585
MDR Text Key39247961
Report Number1219602-2016-00105
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 02/15/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/23/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/01/2020
Device Catalogue Number7205305
Device Lot Number50577084
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/08/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/20/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/04/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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