MAUDE Adverse Event Report: VARIAN MEDICAL SYSTEMS, INC. VARIAN MEDICAL SYSTEMS TRANSFER GUIDE TUBE WITH INTEGRATED QUICK CONNECT FOR AFT; SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED

Model Number GM19001010

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/29/2022

Event Type  malfunction  

Event Description

(b)(6) discovered a deviation in the length of the varian clickfit transfer tube channel used on the varian varisource hdr afterloader.Using varisource measurement wire and ruler, on (b)(6) 2021 the tube measured 119.9cm.On (b)(6) 2022 the same tube measured 122.9 cm.The longer tube may have led to incorrect treatment of patients through underexposure.Patients may have received radiation doses different from prescribed doses.Therapy dates: (b)(6) 2021 - (b)(6) 2022.Fda safety report id# (b)(4).

• Brand Name: VARIAN MEDICAL SYSTEMS TRANSFER GUIDE TUBE WITH INTEGRATED QUICK CONNECT FOR AFT
• Type of Device: SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED
• Manufacturer (Section D): VARIAN MEDICAL SYSTEMS, INC.
• MDR Report Key: 15391341
• MDR Text Key: 299779366
• Report Number: MW5111948
• Device Sequence Number: 1
• Product Code: JAQ
• Combination Product (y/n): 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
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GM19001010
• Device Catalogue Number: 00816389026414
• Device Lot Number: (10)V12
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other