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

Model Number	COREVISION 5X10
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hologic is submitting this report in accordance with 21.Cfr part 803.The submission is based upon the currently available information.The submission of this report does not represent a confirmation of device malfunction involving the hologic products in the event described.A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.We are currently unable to establish a relationship between the device and the issue reported.The device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.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.This is a resubmission of the report submitted on 07/30/2021 submitted under : 1222780-2021-00217 to correct the manufacturer registration number.
Event or Problem Description
It was reported that on july 14th during an imaging procedure for a sample, the specimen fell off the drawer and into the machine.The staff weren´t able to retrieve the sample and the patient had to be rescheduled for a new tissue acquisitions procedure.No other information is available.

• Brand Name: FAXITRON CORE
• Common Device Name: CABINET, X-RAY SYSTEM
• Manufacturer (Section D): HOLOGIC, INC.; 36 apple ridge rd; danubry CT 06810
• MDR Report Key: 12345520
• Report Number: 1220984-2021-00029
• Device Sequence Number: 4333547
• Product Code: MWP
• UDI-Device Identifier: 00857069006005
• UDI-Public: (01)00857069006005(11)170201
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K082432
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/19/2021

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
• Operator of Device: Health Professional
• Device Model Number: COREVISION 5X10
• Device Catalogue Number: COREVISION 5X10
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1