MAUDE Adverse Event Report: HOLOGIC SELENIA DIMENSIONS MAMOGRAPHY SYSTEM 3D; MAMMOGRAPHY SYSTEM

Model Number	SDM-00001-3D
Medical Device Problem Code	Unintended Arm Motion (1033)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/30/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Our field engineer went out the site to check out the unit.She was informed that uncommanded gantry rotation happened occasionally before this incident happened.Two different radiographers left the room with gantry in the cc position, returned to the room and found the gantry upside down (190 degrees).They noted the same error message but they didn't report to us.Our fe ran logs and sent to our technical support team who recommended she replace the following parts; asy-01503, assy, rotary sw w/harness, pcb-00197, assy., c-arm transition bd, pcb-00064, assy, c-arm bd, these parts were replaced and the unit is working as intended.
Event or Problem Description
The radiographer had finished her screening exam and rotated the c-arm to an upright position using the switch behind the detector, and then removed her hand from the switches.When she turned to get a wet wipe to clean the system she wasn't aware that the rotation didn't stop but continued to rotate and it hit her on her left shoulder.There was room for the radiographer to move out of the way as the c-arm continued rotating.When it stopped, it displayed an error that the switch had failed.No intervention was required.

• Brand Name: SELENIA DIMENSIONS MAMOGRAPHY SYSTEM 3D
• Common Device Name: MAMMOGRAPHY SYSTEM
• Manufacturer (Section D): HOLOGIC; 36 & 37 apple ridge road; danbury CT 06810
• MDR Report Key: 5848142
• Report Number: 1220894-2016-00023
• Device Sequence Number: 416691
• Product Code: OTE
• UDI-Device Identifier: 15420045500013
• UDI-Public: 15420045500013
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: PM80003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Radiologic Technologist
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 08/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Radiologic Technologist
• Device Model Number: SDM-00001-3D
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/04/2016
• Initial Report FDA Received Date: 08/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other