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

Model Number SDM-00001-M2D

Device Problem Unintended System Motion (1430)

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

Event Date 09/13/2021

Event Type  malfunction  

Event Description

It was reported that the customer was switching from rmlo to lmlo and they pressed the c-arm movement switch once and it turned all the way upside down.No injury reported.A field engineer (fe) was dispatched to the site to investigate the issue.When the equipment was checked, fe was unable to reproduce the fault.The customer reported to fe that "they used the system following the incident & has used it since with no further issues".Error log files were viewed on site, and no c-arm / vta error messages were found that could explain the reported incident.As of today the investigation is still in progress.

Event Description

The field engineer replaced the c-arm and rear rotation switches as a precaution.Once this was completed the system was working as intended.

Manufacturer Narrative

The c-arm switches and the rear rotary switch were returned to hologic for evaluation; however, the jumper and the earthing cables, and the actuator which is used in combination with the rotary switch, were not returned.Functional testing was performed with the new jumper and earthing cables and the actuator.It was determined that all the switches were working as per the operating specifications therefore a definitive root cause cannot be determined.A review of the complaint history showed no recurring similar events on the reported unit.

• Brand Name: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM
• Type of Device: FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
• Manufacturer (Section D): HOLOGIC, INC; 36 & 37 apple ridge road; danbury CT 06810
• Manufacturer Contact: kristin fornieri ; 36 & 37 apple ridge road; danbury, CT 06810 ; 2037318491
• MDR Report Key: 12614779
• MDR Text Key: 281428885
• Report Number: 1220984-2021-00044
• Device Sequence Number: 1
• Product Code: MUE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P010025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/12/2021

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-00001-M2D
• Device Catalogue Number: SDM-00001-M2D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/13/2021
• Initial Date FDA Received: 10/12/2021
• Supplement Dates Manufacturer Received: 09/13/2021
• Supplement Dates FDA Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• 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