MAUDE Adverse Event Report: BEST THERATRONICS LTD THERATRON; COBALT THERAPY

Model Number EQUINOX

Device Problem Positioning Problem (3009)

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

Event Date 12/24/2013

Event Type  malfunction  

Event Description

A report was received that the radioactive source failed to return to the fully shielded position at the end of the pt treatment.The pt was removed from the room and the source was manually returned to the safe position.

Manufacturer Narrative

Based on past experience it is likely that the cause was foreign material inside the collimator.This is typically rectified by rotating the gentry to the zero position so that any material will fall out.This is what was recommended by btl at the time that the event was reported.The customer subsequently reported that the source had been returned to the safe position and the unit was back in service.This unit has been in use for 7 years without any preventive maintenance performed by best theratronics.The recommended frequency is every 5 years as per the operator manual.The operator normally observes both the unit and the pt at all times during the treatment.Should the source remain in the exposed or partially exposed position at the end of treatment, this would be readily noticed by the operator and the pt evacuated from the room.In this event the collimator also automatically closes to reduce exposure to pt and/or operator.Labeling for the device instructs the operator on the steps to be followed in the event that the source remains in the exposed position at the end of treatment.The source can then be manually returned to the fully shielded position using the emergency return handle provided with the device.Use of the return handle is fully described in the operator's manual.

• Brand Name: THERATRON
• Type of Device: COBALT THERAPY
• Manufacturer (Section D): BEST THERATRONICS LTD; ottawa, ontario 0000
• Manufacturer Contact: mike der schueren ; 413 march road; ottawa, ontario K2K 0-E4 ; CA K2K 0E4 ; 5912100
• MDR Report Key: 3793207
• MDR Text Key: 19022305
• Report Number: 3006946288-2014-00001
• Device Sequence Number: 1
• Product Code: IWB
• Combination Product (y/n): N
• Reporter Country Code: ET
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EQUINOX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/24/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2005
• 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