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

Combination Product (Y/N)

• 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

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