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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SWANN MORTON, LTD CS00SM15 BLADE

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SWANN MORTON, LTD CS00SM15 BLADE Back to Search Results
Model Number CS00SM15
Device Problem Mechanical Problem (1384)
Patient Problem Foreign Body In Patient (2687)
Event Type  malfunction  
Event Description
Blade cs00sm broke off in the patient. The blade was retrieved from the patient and no injury was reported.
 
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Brand NameCS00SM15
Type of DeviceBLADE
Manufacturer (Section D)
SWANN MORTON, LTD
owlerton green
sheffield,
UK
Manufacturer (Section G)
SWANN MORTON, LTD
owlerton green
sheffield,
UK
Manufacturer Contact
kevin walls
33 golden eagle lane
littleton, CO 80127
7209625412
MDR Report Key6731298
MDR Text Key80875386
Report Number9611194-2017-00001
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 07/21/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCS00SM15
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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