MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2012-11-15 for PROTON THERAPY SYSTEM manufactured by Indiana University Cyclotron Operations.
[2982302]
Iuco uses a cyclotron to generate a proton beam that is transmitted to an adjacent cancer treatment center (iu health proton therapy center or iu health ptc) where independent physicians (e. G. Radiation oncologists) use the beam to treat certain cancers. The beam passes through a pt-specific range compensator which is mounted to the end of the "snout". As part of each treatment setup, the therapist mounts the compensator and secures the latches that hold the compensator in place. The therapist must physically verify that the latches are secure - there is no external indication of the latch position. The event involves a compensator falling off of a 20 cm snout onto the pt couch while the pt was being set up for treatment. The gantry was in the treatment position at 280 degrees. The compensator grazed the pt's head and startled the pt, but the pt was not injured. One similar event occurred in (b)(6) 2012 which did not involve a pt.
Patient Sequence No: 1, Text Type: D, B5
[10259654]
This is a unique device (this is the only proton therapy system made by iuco) and as such there is no model number, brand name, serial number or lot number. There are three 20 cm snouts available for use with the device at iu health ptc. Iuco has not distributed any snouts outside of iu health ptc. Based on task analysis of the event, the apparent cause is that the to compensator latch was either not locked or was accidentally released after the compensator was installed. The user installed the compensator and checked the latches so quickly that it was difficult to tell if the user was checking them in accordance with the user instructions, or if the user interaction could have accidentally released the latch. The failure (compensator falling out) could not be reproduced during the task analysis. The user report concluded that the cause of the event was a user failure to secure the compensator. Investigation of the snout itself determined that increasing the spring strength in the compensator latch may reduce the likelihood of use error. While the springs to not play a role once the latches are locked, they do affect how easily the latches lock when they are closed. In response to this eval, the springs have been replaced with stronger springs and a monthly preventive maintenance procedure instituted to verify the force required to actuate the latch lever. In addition, the user will be retrained on the instructions for use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007456386-2012-00002 |
| MDR Report Key | 2857449 |
| Report Source | 05,06,07 |
| Date Received | 2012-11-15 |
| Date of Report | 2012-11-13 |
| Date of Event | 2012-10-17 |
| Date Mfgr Received | 2012-10-17 |
| Device Manufacturer Date | 2010-05-01 |
| Date Added to Maude | 2013-02-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MOIRA WEDEKIND, HEAD |
| Manufacturer Street | 2401 MILO B SAMPSON LANE |
| Manufacturer City | BLOOMINGTON IN 47408 |
| Manufacturer Country | US |
| Manufacturer Postal | 47408 |
| Manufacturer Phone | 8128553603 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROTON THERAPY SYSTEM |
| Product Code | LHN |
| Date Received | 2012-11-15 |
| Returned To Mfg | 2012-10-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INDIANA UNIVERSITY CYCLOTRON OPERATIONS |
| Manufacturer Address | 2401 MILO B SAMPSON LANE BLMGTN IN 47408 US 47408 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-11-15 |