MAUDE Adverse Event Report: HOLOGIC, INC LOCALIZER; MARKER, RADIOGRAPHIC, IMPLANTABLE

Model Number	HB100
Medical Device Problem Code	Electromagnetic Interference (1194)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was received and tested: visual inspection was conducted and there were no signs of physical damage.Functional testing was conducted and device worked as intended.Device was tested using regular fixture with tag and additionally with an external tag and readings were accurate.Hence, the complaint cannot be reproduced.However, video evidence has been provided by the complainant which shows a fluctuation of readings between 10-15 mm.Therefore, the complaint can be confirmed based on this video evidence (refer to files), but it could not be reproduced at the pms laboratory.Causes of the fluctuation can be related to non-device factors.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.
Event or Problem Description
It was reported that during a localizer procedure on (b)(6) 2022, the physician could not locate the localizer tag on the breast and decided to rely on images and scarring tissue to guide to remove the mass.The surgeon was unsure if the correct margins had been removed from the patient and a possibility of having to re-excise the patient was awaiting from pathology results.No other information is available.

• Brand Name: LOCALIZER
• Common Device Name: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer (Section G): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free zone building b24; san jose 20102 ; CR 20102
• MDR Report Key: 15499561
• Report Number: 1222780-2022-00264
• Device Sequence Number: 14719887
• Product Code: NEU
• UDI-Device Identifier: 00855436007037
• UDI-Public: 00855436007037
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K163667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/27/2022

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: HB100
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female