MAUDE Adverse Event Report: ELEKTA INSTRUMENT AB LEKSELL GAMMA KNIFE ICON; SYSTEM, RADIATION THERAPY, RADIONUCLIDE, PRODUCT CODE: IWB

Model Number 1016200

Device Problems Device Operates Differently Than Expected (2913); Positioning Problem (3009)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 03/14/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.

Event Description

It has been reported there may be an offset in stereotactic references - a possible 1.6mm difference found in some icon images.

Manufacturer Narrative

A root cause analysis was conducted involving extensive calibration and measurements.The investigation concludes that the shift is caused by a skewed g-frame caused by asymmetric and high tension in the g-frame attachment screws in combination with extended posts.Multiple use error must occur for the cause to happen.The use errors are deemed unusual since the correct g-frame training and usage is detailed in the ifu and the fiducial error is clearly displayed to the lgp user.

• Brand Name: LEKSELL GAMMA KNIFE ICON
• Type of Device: SYSTEM, RADIATION THERAPY, RADIONUCLIDE, PRODUCT CODE: IWB
• Manufacturer (Section D): ELEKTA INSTRUMENT AB; po box 7593; stockholm, SE103 93; SW SE103 93
• Manufacturer (Section G): ELEKTA INSTRUMENT AB; po box 7593; stockholm, SE103 93; SW SE103 93
• Manufacturer Contact: pms ; linac house; fleming way; crawley, west sussex RH10 -9RR ; UK RH10 9RR
• MDR Report Key: 5540856
• MDR Text Key: 42067000
• Report Number: 9612186-2016-00004
• Device Sequence Number: 1
• Product Code: IWB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K151561
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1016200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other