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

Model Number	HB115
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.H3: 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.6 devices were involved in this case: 1222780-2024-00038, 1222780-2024-00039, 1222780-2024-00040, 1222780-2024-00041, 1222780-2024-00042.
Event or Problem Description
It was reported that on (b)(6) 2023, the patient was on the table under anesthesia, and the reader distance on the screen was jumping around from near to far uncontrollably both in loop and pencil probe settings.4 separate probes were tried and two readers were tried unsuccessfully.Ultrasound was brought in to find the tag and was unsuccessful as well.Troubleshooting such as checking the probe connection with the drape, turning on/off to recalibrate, and removing the system from resting on metal was all tested unsuccessfully.An incision was already made to the patient when the issue occurred.The patient will be returning for a mastectomy at a later date.No additional information available.

• Brand Name: LOCALIZER READER
• Common Device Name: MARKER, RADRIOGRAPHIC, 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: ariel lafuente ; 562 parkway; coyol free zone building b24; san jose 20102
• MDR Report Key: 18632874
• Report Number: 1222780-2024-00043
• Device Sequence Number: 15426133
• Product Code: NEU
• UDI-Device Identifier: 00855436007037
• UDI-Public: (01)00855436007037(11)230609
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K193189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2024

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: HB115
• 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: 01/04/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2024
• Supplement Report FDA Received Date: 05/08/2024
• 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