MAUDE Adverse Event Report: HOLOGIC, INC. FAXITRON; CABINET, X-RAY SYSTEM

Model Number	BIOVISION 10X15
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported and a definitive root cause for the reported event could not be determined.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.
Event or Problem Description
It was reported that on (b)(6) 2021 during a imaging using a faxitron or the images sent to the physician using intellispace pacs had a discrepancy , because of this the physician had to excise additional margins from the patient.Additional information received referred to user error and software error, a technician was able to fix the issue for future tests and explain the customer how to use it properly.No other information is available.

• Brand Name: FAXITRON
• Common Device Name: CABINET, X-RAY SYSTEM
• Manufacturer (Section D): HOLOGIC, INC.; 36 apple ridge rd; danbury CT 06810
• MDR Report Key: 12428634
• Report Number: 1220984-2021-00030
• Device Sequence Number: 5131113
• Product Code: MWP
• UDI-Device Identifier: 00857069006012
• UDI-Public: (01)00857069006012(11)160729
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K091558
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/06/2021

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: Health Professional
• Device Model Number: BIOVISION 10X15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 09/06/2021
• 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