MAUDE Adverse Event Report: ELEKTA LTD PRECISE SERIES LINAC; ACCELERATOR, LINEAR MEDICAL

Model Number 300025

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem Not Applicable (3189)

Event Date 02/25/2016

Event Type  malfunction  

Event Description

The precise table installation manual states the torque figure for the rear anchors to be 160nm.This is incorrect, it should be 250nm.It may be that 3-4 months of precise tables may have been installed with the lower 160nm torque setting.The 250nm identifies any weakness in the installation concrete.160nm may not identify the concrete issues.This could lead to isocentre rotation being outside specification and remain undetected between qa checks.

• Brand Name: PRECISE SERIES LINAC
• Type of Device: ACCELERATOR, LINEAR MEDICAL
• Manufacturer (Section D): ELEKTA LTD; linac house; fleming way; crawley, west sussex RH10 9RR; UK RH10 9RR
• Manufacturer (Section G): ELEKTA LTD; linac house; fleming way; crawley, west sussex RH10 9RR; UK RH10 9RR
• Manufacturer Contact: gpms ; linac house; fleming way; crawley, west sussex RH10 -9RR ; UK RH10 9RR
• MDR Report Key: 5619282
• MDR Text Key: 44012439
• Report Number: 9617016-2016-00003
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K051932
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 300025
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other