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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERILMED, INC.; ARTHROSCOPE
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STERILMED, INC.; ARTHROSCOPE Back to Search Results
Model Number SMI7205313
Device Problem Metal Shedding Debris (1804)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/13/2014
Event Type  malfunction  
Event Description
It was reported that during a arthroscopy shoulder/rotator cuff procedure the device was utilized and shavings began to appear in the surgery/wound area.The device was replaced.The shavings were removed with irrigation and suction.Time was needed to remove the shavings.There was no side-loading.There was no patient injury.
 
Manufacturer Narrative
The device was not returned to the manufacturer as of the date of this report.A supplemental report will be submitted after device evaluation if the device is received.
 
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Brand Name
NA
Type of Device
ARTHROSCOPE
Manufacturer (Section D)
STERILMED, INC.
maple grove MN
Manufacturer Contact
patricia kaufman
11400 73rd ave. north
maple grove, MN 55369
7634883211
MDR Report Key4345134
MDR Text Key5143724
Report Number2134070-2014-00200
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K012536
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 11/13/2011
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2015
Device Model NumberSMI7205313
Device Catalogue Number7205313
Device Lot Number1795830
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/13/2014
Initial Date FDA Received12/08/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age52 YR
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