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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER CORPORATION HD 2.7MM X 30 DEGREE STUBBY ARTHROSCOPE J-LOCK A/C

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STRYKER CORPORATION HD 2.7MM X 30 DEGREE STUBBY ARTHROSCOPE J-LOCK A/C Back to Search Results
Model Number 0502027030
Device Problem Poor Quality Image (1408)
Patient Problem Insufficient Information (4580)
Event Date 01/15/2021
Event Type  malfunction  
Event Description
Stryker arthroscope malfunction.Physician is not satisfied with the mechanism of the stryker 2.7mm 30 degree arthroscope.The physician was unable to complete the surgery due to the inability to see a clear picture via the scope because the picture was blurry.
 
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Brand Name
HD 2.7MM X 30 DEGREE STUBBY ARTHROSCOPE J-LOCK A/C
Type of Device
ARTHROSCOPE
Manufacturer (Section D)
STRYKER CORPORATION
5900 optical ct
san jose CA 95138
MDR Report Key11854909
MDR Text Key251679737
Report Number11854909
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 05/05/2021,02/09/2021
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 No Information
Device Model Number0502027030
Device Catalogue Number0502-027-030
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/05/2021
Device Age2 MO
Date Report to Manufacturer05/20/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/20/2021
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age16060 DA
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