BRACHYVISION

Report

Report Number: 1124791-2010-00003
Event Type: Other
Date Received: June 4, 2010
Date of Event: May 6, 2010
Report Date: June 4, 2010
Manufacturer: VARIAN MEDICAL SYSTEMS, INC.
Product Code: MUJ
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NZ
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THIS REPORT IS BASED ON INFORMATION RECEIVED FROM A THIRD PARTY OR DEVELOPED BY VARIAN MEDICAL SYSTEMS, INC. WHILE THE REPORTED EVENT IS BEING INVESTIGATED, SOME OF THE FACTS ARE AS YET UNVERIFIED. BY SUBMITTING THIS REPORT THE COMPANY IS NOT ADMITTING THAT THE PRODUCT IDENTIFIED HAS MALFUNCTIONS, IS DEFECTIVE, OR HAS CAUSED OR CONTRIBUTED TO A SERIOUS INJURY OR DEATH. INFORMATION PROVIDED IN THIS REPORT IS BASED ON THE ASSUMPTION THAT THE INFORMATION CURRENTLY AVAILABLE IS TRUE AND ACCURATE.

Description of Event or Problem · 1

USER SITE DELIVERED BRACHYTHERAPY TREATMENTS WITH A 1.4MM PROXIMAL POSITIONAL ERROR FOR YEARS. THE ROOT CAUSE OF THE POSITIONAL DISCREPANCY WAS DUE TO INCORRECT USER INPUT VALUE FOR THE SOURCE CENTER DISTANCE FROM TIP. THE USER SITE HAD CHANGED THE FACTORY DEFAULT SETTING AND DID NOT PERFORM A SYSTEM VERIFICATION TEST WHICH WOULD HAVE CAUGHT THE DISCREPANCY. THE USER SITE HAS NOT REPORTED THEIR CONCLUSIONS ON THE CLINICAL IMPACT AT THIS TIME. IT IS UNLIKELY THAT THE 1.4MM POSITIONAL CHANGE WILL HAVE ANY CLINICAL SIGNIFICANCE TO THE DELIVERED TREATMENTS. IF INFORMATION BECOMES AVAILABLE INDICATING NEGATIVE PT EFFECTS, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	BRACHYVISION	BRACHYTHERAPY TREATMENT PLANNING SOFTWAR	MUJ	VARIAN MEDICAL SYSTEMS, INC.	6.5-8.9	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Other	GAMMAMED 12I (T) AFTERLOADER\| H630207