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

Device Problem Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/05/2014

Event Type  malfunction  

Event Description

The customer reported that the 'table iso center shifted by 4mm.' this was detected during normal monthly qa.

Manufacturer Narrative

Very little information was available from the reporting site.Manufacturer investigation ongoing.

Manufacturer Narrative

The manufacturer is unable to establish the root cause of this issue as the reporting site has not provided adequate information and is non responsive to requests for information.Based off the limited information provided a potential precise table isocentre shift of 4mm would lead to a tolerable risk.The issue has been corrected on site.Based off the information provided it is not possible to propose any further corrective actions on this issue.The manufacturer was unable to determine if there were any similar incidents because the root cause could not be established.If further information becomes available from the reporting site the manufacturer will reopen the investigation on this issue.If no further information is provided there will not be any more investigation.

• 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: 4356143
• MDR Text Key: 5200973
• Report Number: 9617016-2014-00016
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K963624
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 03/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2014
• 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: Reuse
• Patient Sequence Number: 1