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

Model Number	HB300-05
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation was conducted: it was reported that during a localizer procedure on an unknown date in october 2025, "patient with right breast cancer undergoing rf [radiofrequency] tag localized partial mastectomy and sentinel node biopsy.Rf tag placed prior to surgery and tag signal confirmed prior to incision.During procedure tag could not be localized using detector unit.Signal was detected without tag number.Intermittently the tag signal with tag number was identified.We ultimately visualized the tag, and the probe did not identify a signal while directly on the tag.This resulted in the creation of a larger lumpectomy specimen including an additional superior margin." no further information is available.The device was not available for return; visual and functional analysis/testing could not be conducted for the described event.Cause/root cause: the device was not returned for this complaint.Investigation for this issue was conducted through customer provided information, historical data review, similar complaints analysis, and product design evaluation.Without the returned device, it is not possible to confirm a definitive root cause of the issue.Conclusion: the reported issue could not be confirmed because the device was not returned.Capa/hra/ncr/scar are not deemed required at this moment by this event.Future events will be monitored and trended.Device history record (dhr) review: the dhr review was not conducted since the lot/serial number was not provided by the complainant.Medsun report received: (b)(4).
Event or Problem Description
It was reported that during a localizer procedure on an unknown date in (b)(6) 2025, "patient with right breast cancer undergoing rf [radiofrequency] tag localized partial mastectomy and sentinel node biopsy.Rf tag placed prior to surgery and tag signal confirmed prior to incision.During procedure tag could not be localized using detector unit.Signal was detected without tag number.Intermittently the tag signal with tag number was identified.We ultimately visualized the tag, and the probe did not identify a signal while directly on the tag.This resulted in the creation of a larger lumpectomy specimen including an additional superior margin." no further information is currently available.

• Brand Name: LOCALIZER
• Common Device Name: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): HOLOGIC; 250 campus drive; marlborough MA 01752
• Manufacturer (Section G): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: dara smithers ; 600 technology drive; newark, DE 19702
• MDR Report Key: 23809834
• Report Number: 1222780-2025-00634
• Device Sequence Number: 15786338
• Product Code: NEU
• UDI-Device Identifier: 00855436007143
• UDI-Public: 00855436007143
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/15/2025

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: HB300-05
• Device Catalogue Number: HB300-05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown