LEKSELL GAMMA KNIFE PERFEXION WITH EXTEND FRAME SYSTEM 1009622

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05,06 report with the FDA on 2010-09-27 for LEKSELL GAMMA KNIFE PERFEXION WITH EXTEND FRAME SYSTEM 1009622 manufactured by Elekta Instrument Ab.

Event Text Entries

[20744371] During setup of pt at ct, it was difficult to achieve good results at rct measurement. The rod turned out to have loosened from the mouthpiece. All mouthpieces at customers were then checked by hand force prior to the next setup trial. After ct prior to treatment, the same thing happened again. Size of the mouthpiece was xl p2.
Patient Sequence No: 1, Text Type: D, B5


[20823158] Investigation results: a failure of an extend mouthpiece was found during a pt setup. The anterior fixation bar of the frontpiece came loose from the dental impression tray. The joint between the anterior fixation bar and the dental impression tray is glued using cyanoacrylate glue. The bond gap has been too large in some mouthpieces, resulting in a too small contact surface between the two parts and as a consequence a too weak joint. The result is that the glue line can break when the mouthpiece is twisted, which leads to either a play between the anterior fixation bar and the dental impression tray, or that the dental impression tray comes loose. It is not possible to determine if the glue lines on a mouthpiece are bad, neither by visual inspection nor by pulling or bending the extend mouthpiece. Corrective action: elekta instruments (b)(4) issued an important notice a342 "potential failure of the extend mouthpiece" to affected users instructing them to return the old mouthpieces to elekta instruments (b)(4) which will be replaced with new mouthpieces. The corrective actions have been identified within the (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9612186-2010-00005
MDR Report Key1851032
Report Source00,01,05,06
Date Received2010-09-27
Date of Report2010-09-24
Date of Event2010-09-16
Date Mfgr Received2010-09-17
Date Added to Maude2012-01-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer CitySTOCKHOLM
Manufacturer CountrySW
Manufacturer Phone293654250
Single Use3
Remedial ActionNO
Previous Use Code3
Removal Correction Number9612186-092710-016-C
Event Type3
Type of Report3

Device Details

Brand NameLEKSELL GAMMA KNIFE PERFEXION WITH EXTEND FRAME SYSTEM
Generic NameSYSTEM, RADIATION THERAPY, RADIONUCLIDE
Product CodeIWB
Date Received2010-09-27
Catalog Number1009622
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerELEKTA INSTRUMENT AB
Manufacturer AddressSTOCKHOLM SW


Patients

Patient NumberTreatmentOutcomeDate
10 2010-09-27

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