MAUDE Adverse Event Report: BRAINLAB AG M3 (MICRO-MULTILEAF COLLIMATOR); M3 MICRO-MULTI-LEAF COLLIMATOR

Model Number 41600-3

Device Problem Misassembly by Users (3133)

Patient Problem No Patient Involvement (2645)

Event Date 01/20/2016

Event Type  No Answer Provided  

Manufacturer Narrative

A risk to health could not be excluded for these specific circumstances, although: no injury of a patient or user or any other person has occurred (and no patient in the treatment room at the time of event).There is no indication of a systematic error or malfunction of the brainlab device.There is no indication that the brainlab device would not have worked as intended.Corresponding measures to minimize this anticipated risk as low as reasonably practicable are already in place.According to the results of the brainlab investigation and the information provided by the hospital, it can be concluded that the root cause for the m3 falling down is that an inadequate and insufficient attachment procedure of the m3 micro-multileaf collimator was performed in this specific case.The mounting-procedure as described in the corresponding user guide was not followed; specifically the device was not correctly locked into position, and the status of the relevant gantry accessory mount interlock lights was not reviewed.Therefore the removable m3 micro-multileaf collimator was not properly mounted and was still able to slide out.Investigation by brainlab (on-site and off-site) has shown that the fixation mechanism of this m3 worked as intended.Even with the m3 damaged after the event, the m3 could still be mounted to the accessory mount with all locking mechanisms engaging.There is no indication of an error or malfunction of the device, the device worked as intended.Corresponding measures to minimize this anticipated risk as low as reasonably practicable are already in place.The m3 micro-multileaf collimator has been returned from this site to brainlab after the event for repair.Despite according to the hospital the operators at this site are informed about the correct procedure to mount the m3 on the linear accelerator, brainlab intends to offer an additional training to this hospital.

Event Description

A hospital technician positioned the removable brainlab m3 micro-multileaf collimator in the interface mount on the linear accelerator and afterwards started rotating the gantry of the linear accelerator from the 6 o'clock position upwards.During that rotation the m3 slid out of the gantry interface and fell down.This occurred during set-up of the treatment room before patient treatments.According to the hospital: there was no patient in the treatment room at the time of the event.No user or other person was injured by the m3 sliding out.There was no damage to any other hospital equipment of this site.

• Brand Name: M3 (MICRO-MULTILEAF COLLIMATOR)
• Type of Device: M3 MICRO-MULTI-LEAF COLLIMATOR
• Manufacturer (Section D): BRAINLAB AG; kapellenstrasse 12; feldkirchen, 85622 ; GM 85622
• Manufacturer (Section G): BRAINLAB AG; kapellenstrasse 12; feldkirchen, 85622 ; GM 85622
• Manufacturer Contact: markus hofmann ; kapellenstrasse 12; feldkirchen, 85622 ; GM 85622 ; 89 9915680
• MDR Report Key: 5431390
• MDR Text Key: 38079228
• Report Number: 8043933-2016-00004
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K020860
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 41600-3
• Device Catalogue Number: 41600-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2005
• 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
• Patient Outcome(s): Other