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

Catalog Number	902615
Medical Device Problem Code	Flare or Flash (2942)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Witness statements indicate the instrument was powered on during the event.The power supply used on this instrument is fully safety-certified and equipped with over-current, over-voltage and over-temperature safety protections.Based on picture evidence of the incident, the water caused a short circuit inside the power supply, which caused excessive heating of materials inside the power supply.Examination of the picture evidence showed that the excessive heat was contained entirely within the power supply casing, with no damage seen for the cables above the power supply, indicating the heat did not damage adjacent components.The panther instrument is designed and independently safety-certified to not catch fire by utilizing fire-resistant and self-extinguishing materials.However, the instrument is not designed to be doused or immersed in water.Although the instrument was exposed to a large volume of fluid it failed safely as designed, and according to iec 61010-1 safety requirements.
Event or Problem Description
On july 16, 2025, a customer reported that a water pipe burst over the top of their panther in their lab, causing water to get inside their panther (sn (b)(6)).The panther's power supply short circuited, with customer reporting that they observed smoke and sparks that turned into a ¿mini fire¿ that extinguished itself.Customer unplugged the power cord for the panther and no further actions were required.There were no reports of injuries or health concerns due to this event.The customer's second, adjacent panther was unaffected by the incident and was assessed by a hologic field service engineer and cleared for use.

• 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: zachary hansen ; 10210 genetic center drive; san diego, CA 92121 ; 9519739240
• MDR Report Key: 22821647
• Report Number: 2024800-2025-00054
• Device Sequence Number: 9750429
• Product Code: OOI
• UDI-Device Identifier: 15420045504141
• UDI-Public: 15420045504141
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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

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: 07/16/2025
• Initial Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown