MAUDE Adverse Event Report: HOLOGIC, INC. PANTHER INSTRUMENT; HOLOGIC PANTHER, INSTRUMENT SYSTEM

Catalog Number	902615
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On june 16, 2025, a customer reported to hologic that the panther instrument sample bay canopy was loose.During user maintenance, the sample canopy door did not stay up and fell down and hit the customer in the face, knocking her glasses to the floor.The customer confirmed she was fine and refused medical attention.Hologic has not been informed of any treatment or any adverse outcomes related to this event.
Additional Manufacturer Narrative
A hologic field service engineer was dispatched to the customer site and found the right canopy door spring was leaking oil and was not holding the door up even when it was in the fully vertical position.The hologic fse replaced both canopy door springs.Hologic fse confirmed the sample bay canopy was able to stay up in fully vertical position after service.Hologic performed a risk assessment and noted no product impact.Customer impact was assessed as possible inconvenience and risk of a minor, non-threatening injury if the canopy door strikes the operator at a sufficient force.The customer refused medical attention and 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: jiayi zheng ; 10210 genetic center drive; san diego, CA 92121
• MDR Report Key: 22484996
• Report Number: 2024800-2025-00041
• Device Sequence Number: 8668818
• Product Code: OOI
• UDI-Device Identifier: 15420045504141
• UDI-Public: 15420045504141
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 07/09/2025

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
• Device Catalogue Number: 902615
• Device Lot Number: N/A
• 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: 06/16/2025
• Initial Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown