MAUDE Adverse Event Report: ARTHREX, INC. ARTHROSCOPY PUMP TUBING ARTHROSCOPE

Model Number AR-6410

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 10/27/2020

Event Type  malfunction  

Event Description

Arthroscopy pump tubing had a leak at the hub.

• Brand Name: ARTHROSCOPY PUMP TUBING
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): ARTHREX, INC.
• MDR Report Key: 10829379
• MDR Text Key: 216185412
• Report Number: MW5097807
• Device Sequence Number: 1
• Product Code: HRX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/04/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: AR-6410
• Device Catalogue Number: AR-6410
• Device Lot Number: 37378527
• 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?

Is the Device Single Use?

• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage