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: 10829388
• MDR Text Key: 216192686
• Report Number: MW5097808
• 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

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/10/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Weight: 112