MAUDE Adverse Event Report: STRYKER CORPORATION FLOSTEADY; ARTHROSCOPE

Device Problem Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 03/03/2021

Event Type  malfunction  

Event Description

At the beginning of the case the flosteady arthroscopy pump was hooked up and working.But, shortly after the fluid stopped.While looking for a kink in the tubing it was noticed the diaphragm in the flow chamber looked over inflated and irregular.The pump was turned off and the tubing was replaced by a new one.The next tubing worked without issue.

• Brand Name: FLOSTEADY
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical ct; san jose CA 95138
• MDR Report Key: 11919326
• MDR Text Key: 253721587
• Report Number: 11919326
• 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: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/17/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16425 DA