MAUDE Adverse Event Report: STRYKER; 4MM 30 DEGREES SCOPE

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.

• Brand Name: STRYKER
• Type of Device: 4MM 30 DEGREES SCOPE
• MDR Report Key: 5597758
• MDR Text Key: 43500319
• Report Number: MW5061839
• Device Sequence Number: 1
• Product Code: FAJ
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 04/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 502477031
• Device Catalogue Number: 502477031
• Device Lot Number: 989303
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 55 YR
• Patient Weight: 74