MAUDE Adverse Event Report: HOLOGIC, INC SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM, 2D; FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Model Number SDM-05000-2D3

Device Problem Unintended System Motion (1430)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/22/2023

Event Type  malfunction  

Event Description

It was reported that on (b)(6) during a selenia dimensions procedure the footswitch was stuck which caused the gantry to continue the movement when the pedal was released and the customer had to hit the emergency stop as patient was in the room.A field engineer examined the equipment and determined that the footswitches needed replacement.The footswitches have been dispatched and are awaiting to be received by the customer for repairs.No patient or staff injury reported.

• Brand Name: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM, 2D
• Type of Device: FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
• Manufacturer (Section D): HOLOGIC, INC; 36 & 37 apple ridge road; danbury CT 06810
• Manufacturer (Section G): HOLOGIC, INC.; 36 & 37 apple ridge road; danbury CT 06810
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free zone building b24; san jose 20102
• MDR Report Key: 17273455
• MDR Text Key: 318654821
• Report Number: 1220984-2023-00053
• Device Sequence Number: 1
• Product Code: MUE
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: P010025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2023

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
• Device Operator: Health Professional
• Device Model Number: SDM-05000-2D3
• Device Catalogue Number: SDM-05000-2D3
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/22/2023
• Initial Date FDA Received: 07/06/2023
• Supplement Dates Manufacturer Received: 06/22/2023
• Supplement Dates FDA Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/19/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1