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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERILMED, INC.
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STERILMED, INC. Back to Search Results
Model Number ETHMCL20
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Injury (2348)
Event Type  malfunction  
Event Description
It was reported that the device misfired and severed a small vessel.After the event, it was realized that there was no clip.There was nothing done to repair the vessel.Another device was used to complete the procedure.There was no pt injury.
 
Manufacturer Narrative
The device was returned to the mfr and is awaiting investigation.A supplemental report will be filed when the investigation is complete.
 
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Brand Name
NA
Manufacturer (Section D)
STERILMED, INC.
11400 73rd ave. north
maple grove MN
Manufacturer Contact
patricia kaufman
11400 73rd ave. north
maple grove, MN 55369
MDR Report Key4355710
MDR Text Key5179181
Report Number2134070-2014-00202
Device Sequence Number1
Product Code NMJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K033579
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/18/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2014
Device Model NumberETHMCL20
Device Catalogue NumberETHMCL20
Device Lot Number1625943
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer12/16/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/18/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/07/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial
Patient Sequence Number1
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