bmet assignment 4 - IATION THERAPY Model Number C Event...

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DIATION THERAPY
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Model Number C Event Date 10/24/2007 Event Type Injury Patient Outcome Other; Manufacturer Narrative Mfr. Received official notification of this adverse event on nov. 2, 2007 from outside sources. To date, the site did not provide an official notification to mfr of this adverse event. Add'l comments: during the pre-treatment setup and simulation mri imaging, a "feet first" scan technique was used with the pt positioned in the mri scanner "head first". This had the effect of reversing the axial images left to right. The standard of practice in gamma knife radiosurgery is to position the pt in the mri scanner "head first" utilizing the "head first" scan technique. The gamma knife authorized medical physicist (amp) failed to recognize the scanning error when importing the mri images into the gamma knife treatment planning computer and subsequently registered them as "head first". The quality assurance checks did not recognize or indicate that the images were reversed prior to the procedure. Summary: this user error resulted in the wrong side of the pt being targeted and treated, i. E. The left cerebellum was targeted and treated rather than the right cerebellar lesion. The leksell gamma knife did not malfunction or contribute to this adverse event. Event Description Due to a left - right reversal of the treatment planning mri images by the user, the pt's left side was targeted and treated rather than the right side. The collimator diameter selected for treatment was 18 mm, thus resulting in some overlap of the delivered 50% isodose volume with the correct intended target lesion volume. The event resulted in approx 7% of the lesion volume receiving the prescribed dose of 18 gy to the 50% isodose, rather than the preferred 95% of the lesion volume. Search Alerts/Recalls new search | submit an adverse event report Brand Name LEKSELL GAMMA KNIFE Type of Device RADIATION THERAPY Manufacturer (Section D)
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stockholm 441 293 654250 Device Event Key 930168 MDR Report Key 956016 Event Key 917863 Report Number 9612186-2007-00005 Device Sequence Number 1 Product Code IWB Report Source Manufacturer Source Type Health Professional,User facility Reporter Occupation UNKNOWN Type of Report Initial Report Date 11/29/2007 1 Device Was Involved in the Event 1 Patient Was Involved in the Event Date FDA Received 11/29/2007 Is This An Adverse Event Report? Yes
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bmet assignment 4 - IATION THERAPY Model Number C Event...

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