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

Model Number SDM-05000-3D2

Device Problem Device Handling Problem (3265)

Patient Problems Bone Fracture(s) (1870); No Code Available (3191)

Event Date 03/29/2016

Event Type  Injury  

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 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
• Type of Device: MAMMOGRAPHY SYSTEM
• Manufacturer (Section D): HOLOGIC; 36 & 37 apple ridge road; danbury CT 06810
• Manufacturer (Section G): HOLOGIC, INC.; 36 & 37 apple ridge road; danbury CT 06810
• Manufacturer Contact: debra rosenberg ; 36 & 37 apple ridge road; danbury, CT 06810 ; 2032074512
• MDR Report Key: 5619904
• MDR Text Key: 44037341
• Report Number: 1220894-2016-00003
• Device Sequence Number: 1
• Product Code: OTE
• UDI-Device Identifier: 15420045500013
• UDI-Public: 15420045500013
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PO8003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Medical Technologist
• Device Model Number: SDM-05000-3D2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other