FDA Adverse Event Injury Summary report: N

FAXITRON

MDR report key: 12428634 · Received September 6, 2021

Report

Report Number: 1220984-2021-00030
Event Type: Injury
Date Received: September 6, 2021
Date of Event: July 26, 2021
Report Date: September 6, 2021
Manufacturer: HOLOGIC, INC.
Product Code: MWP
UDI-DI: 00857069006012
PMA / PMN Number: K091558
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

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.

Description of Event or Problem · 1

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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1326030	FAXITRON	CABINET, X-RAY SYSTEM	MWP	HOLOGIC, INC.	BIOVISION 10X15		00857069006012

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other