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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INCISOR, 5.5MM,EP-1,DSPL BLADE SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. INCISOR, 5.5MM,EP-1,DSPL BLADE SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 7205314
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/12/2018
Event Type  Malfunction  
Event Description

It was reported that during the procedure, when it was using the 5,5 mm blade, some silver particles were observed in the tissue, the doctor realized that they were from the blade when it was used with the shaver handpiece, the particles were removed from the tissue by irrigation - suction. No patient injury was reported.

 
Manufacturer Narrative

Examination was not possible, as the device has not been returned. The investigation could not draw any conclusions about the reported event without the return of the device. A review of the non-conformities database was performed which confirmed no abnormalities were reported with this lot during manufacture. A complaint history review identified no additional complaints for this manufactured lot.

 
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Brand NameINCISOR, 5.5MM,EP-1,DSPL BLADE
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
jim gonzales
7000 west william cannon drive
austin, TX 78735
MDR Report Key7405316
MDR Text Key104818700
Report Number1219602-2018-00418
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 DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 04/27/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/06/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number7205314
Device Catalogue Number7205314
Device LOT Number50632650
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/12/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/22/2016
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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