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

Catalog Number	902615
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/23/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The panther/ panther fusion system operator¿s manual states: ¿to reduce the risk of developing stress injuries, take frequent breaks from repetitive tasks like opening and closing tubes.¿ repetitive strain injuries (rsis) are related to multiple factors including workstation set ups, multiple jobs performed by one operator, activities outside of work, or general susceptibility profiles of individuals.As of (b)(6) 2026, the customer has not reported any additional issues.H3 other text: other.
Event or Problem Description
On february 23, 2026, hologic sales reported on behalf of a customer that on (b)(6) 2026, an operator injured their back while handling the liquid waste bottle on the panther instrument (sn: (b)(6)).Due to the injury, the operator required medical attention and was reported to be out for several weeks.Customer requested the weight of the panther liquid waste bottle when full.The maximum weight expectation for a full panther liquid waste container should not exceed 20 lbs.And was measured to be 14.6 pounds during panther verification testing.Customer did not provide any additional information regarding the injury.

• 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: amy holtgraver ; 10210 genetic center drive; san diego, CA 92121 ; 8584108236
• MDR Report Key: 24619545
• Report Number: 2024800-2026-00014
• Device Sequence Number: 9586288
• Product Code: OOI
• UDI-Device Identifier: 15420045504141
• UDI-Public: 15420045504141
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 03/17/2026

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
• 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: 02/23/2026
• Initial Report FDA Received Date: 03/17/2026
• 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