MAUDE Adverse Event Report: HOLOGIC, INC SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM

Model Number	SDM-SYS-9000-3D
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported foot switch was returned to hologic for investigation and the reported issue was duplicated during testing.The source of the issue was that the molded cable strain relief was broken causing the internal wires to cross talk.This intermittent c-arm motion issue was not design related or a machine operational issue, but a result of damage to the cable from mishandling or accidental breakage.
Event or Problem Description
It was reported that the foot switch was causing intermittent c-arm motion.If the foot switch was bumped the c-arm was moving on its own.No injury reported.A field engineer was dispatched to the site and was not able to reproduce the reported issue.The foot switch was replaced and the system was working as intended.
Additional Manufacturer Narrative
Correction to section g3.Date received by manufacturer is 11/20/2020.

• Brand Name: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM
• Common Device Name: MAMMOGRAPHY SYSTEM
• Manufacturer (Section D): HOLOGIC, INC; 36 & 37 apple ridge road; danbury CT 06810
• MDR Report Key: 10968295
• Report Number: 1220984-2020-00077
• Device Sequence Number: 982322
• Product Code: OTE
• UDI-Device Identifier: 15420045505636
• UDI-Public: (01)15420045505636
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P080003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SDM-SYS-9000-3D
• Device Catalogue Number: SDM-SYS-9000-3D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Initial Date Received by Manufacturer: 11/20/2020
• Supplement Date Received by Manufacturer: 11/20/2020
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 12/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1