MAUDE Adverse Event Report: Hologic, Inc. Panther Instrument; HOLOGIC PANTHER, INSTRUMENT SYSTEM

Catalog Number	902615
Medical Device Problem Code	Device Contaminated at the User Facility (4064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On july 8, 2026, customer reported that they observed black-colored dust in the waste drawer of their panther plus instrument (serial number (b)(6)) following maintenance.Upon inspecting the instrument, customer reported that the vacuum filter was improperly installed several months prior.No harm, injury, or incorrect results were reported as a result of the black dust.Hologic has not been informed of any adverse outcomes related to this issue.
Additional Manufacturer Narrative
Per the panther operator¿s manual and the instructions on the waste drawer, the vacuum filter should be installed with the flow arrow pointing up and the word ¿outlet¿ visible on the top of the filter.Backwards installation of the vacuum filter can result in black dust being expelled from the instrument.Hologic investigation confirmed the customer had ignored the vacuum filter install instructions on the waste drawer and had improperly installed the vacuum filter back in march 2026.Hologic field service engineer serviced the panther plus instrument sn (b)(6) at the customer site and confirmed the black carbon media was present at the exterior vents and inside of the instrument.Hologic field service engineer performed cleaning of the panther plus instrument and ensured a new vacuum filter was installed in the correct orientation.No harm, injury, or incorrect results were reported as a result of the black dust.Hologic has not been informed of any adverse outcomes related to this issue.

• Brand Name: Panther Instrument
• Common Device Name: HOLOGIC PANTHER, INSTRUMENT SYSTEM
• Manufacturer (Section D): Hologic, Inc.; 10210 genetic center drive; san diego CA 92121
• Manufacturer (Section G): Hologic, Inc.; 10210 genetic center drive; san diego CA 92121
• Manufacturer Contact: grace nareau ; 10210 genetic center drive; san diego, CA 92121
• MDR Report Key: 50020089
• Report Number: 2024800-2026-00050
• Device Sequence Number: 10514736
• Product Code: OOI
• UDI-Device Identifier: 15420045504141
• UDI-Public: 15420045504141
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K171963
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2026

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
• Device Catalogue Number: 902615
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2026
• Initial Report FDA Received Date: 07/27/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown