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

Model Number	SDM-05000-3D2
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Code Available (3191)
Date of Event	03/29/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Our fe called this in as he was told of the incident.He had been at the site the week before for a different service and noticed the cabinet and that it wouldn't allow the 90 degree rotation and explained to the site manager that the cabinet had to be removed.He has tested all switches on the c-arm and found no evidence of any malfunction.The site has stated hologic has no responsibility and that the system did not malfunction.
Event or Problem Description
A cabinet had been placed in the mammography room, which prevented the c-arm from moving to 90 degrees.A technologist and her manager were trying to measure where the cabinet needed to be cut and the technologist angled the c-arm onto the managers hand.The manger sustained a broken finger and part of the finger stayed on the cabinet requiring a skin graph.

• 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: 5619904
• Report Number: 1220894-2016-00003
• Device Sequence Number: 16192755
• Product Code: OTE
• UDI-Device Identifier: 15420045500013
• UDI-Public: 15420045500013
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: PO8003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/27/2016

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: Medical Technologist
• Device Model Number: SDM-05000-3D2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2016
• 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