GAMMAMED PLUS HDR AFTERLOADING SYSTEM
Received Aug 8, 2011 · Event occurred Jul 14, 2011
Report 9612638-2011-00006 · MDR key 2240875
Device
Generic name
System, Applicator, Radionuclide, R-c
Manufacturer
Varian Medical Systems Haan GmbhModel number
H64Product problems
- Break
- Nonstandard Device
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A CUSTOMER CALLED TO REPORT THAT THE TANDEM (B)(4) BROKE AT THE STOPPER AS IT WAS INSERTED INTO THE PT. THE CUSTOMER SWITCHED TO A DIFFERENT PROBE AND PT WAS TREATED SUCCESSFULLY. NO UNUSUAL FORCE WAS USED PER THE PHYSICIAN. NO PT INJURY OR TREATMENT MISADMINISTRATION WAS REPORTED.
Additional Manufacturer Narrative
THE CUSTOMER ALLEGATION HAS BEEN CONFIRMED: THE TANDEM GM BROKE AS IT WAS INSERTED INTO THE PT. VARIAN INVESTIGATION HAS DETERMINED THAT THIS ISSUE IS THE RESULT OF A FAULTY WELD/ WELDING PROCESS. THIS ISSUE HAS BEEN PREVIOUSLY INVESTIGATED AND REPORTED. VARIAN MODIFIED ITS WELDING PROCESS FOR INTRAUTERINE PROBES. A CAPA HAS BEEN ISSUED AND FURTHER ACTIONS WILL BE ADDRESSED IN VARIAN'S CAPA PROCESS. ALL CORRECTIVE ACTION WILL BE REPORTED UNDER THE GUIDELINES OF 21 CFR PART 806. NO ADD'L FOLLOW UP TO THIS MDR IS EXPECTED.
Remedial action
- Recall