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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER 4MM 30 DEGREES SCOPE
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STRYKER 4MM 30 DEGREES SCOPE Back to Search Results
Model Number 502477031
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Information (3190)
Event Date 04/08/2016
Event Type  Injury  
Event Description
Pt. Had left knee medial meniscectomy and debridement. There was a metal piece 1-2mm in size visualized on pleuo after insertion of the lens. Event abated after use stopped or dose reduced: no.
 
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Brand NameSTRYKER
Type of Device4MM 30 DEGREES SCOPE
MDR Report Key5597758
MDR Text Key43500319
Report NumberMW5061839
Device Sequence Number1
Product Code FAJ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number502477031
Device Catalogue Number502477031
Device Lot Number989303
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/20/2016 Patient Sequence Number: 1
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