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

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.

• 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 Key: 11854909
• MDR Text Key: 251679737
• Report Number: 11854909
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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 Number: 0502027030
• Device Catalogue Number: 0502-027-030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/05/2021
• Device Age: 2 MO
• Date Report to Manufacturer: 05/20/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16060 DA