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

Model Number	PANTHER INSTRUMENT SYSTEM, CONTINUOUS FLUID AND WASTE
Medical Device Problem Code	Power Conditioning Problem (1474)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The hologic field service engineer (fse) inspected the customer's lab and noticed the electrical wiring was not properly grounded from the source.Fse noted the wiring issue impacted all electrical devices in the lab.A 3rd party contractor was contacted to rewire the lab from the source, and new earthing cables were installed and securely attached.After the contractor's work was completed, the new voltages and ground stability of less than 0.1v were achieved, which resolved the issue.Fse noted there were no additional electric shocks on the panther plus instrument or throughout the lab.Hologic performed a risk assessment and noted minimal to no product impact.Hologic has not learned of any adverse patient outcomes due to this event.H3 other text: other.
Event or Problem Description
On may 26th, 2025, a hologic field service engineer (fse) reported to hologic that a customer was experiencing repeated electric shocks while using their panther plus instrument serial number (b)(6).Customer noted that the issue mainly occurred during monthly maintenance and while loading samples.Fse noted that the electric shock felt like static discharge with no pain experienced.Customer did not report any injuries from the electric shocks and did not seek any medical treatment.Customer was instructed to discontinue use of the instrument until the issue was resolved, so the instrument was powered down, disconnected from the power supply, and covered to prevent use.Hologic has not learned of any adverse patient outcomes due to this event.

• 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: geovan rich ; 10210 genetic center drive; san diego, CA 92121 ; 6199972348
• MDR Report Key: 22302284
• Report Number: 2024800-2025-00036
• Device Sequence Number: 15610450
• Product Code: OOI
• UDI-Device Identifier: 15420045504141
• UDI-Public: 15420045504141
• Combination Product (Y/N): N
• Initial Reporter Country: KE
• 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): 06/20/2025

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 Model Number: PANTHER INSTRUMENT SYSTEM, CONTINUOUS FLUID AND WASTE
• 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: 05/26/2025
• Initial Report FDA Received Date: 06/20/2025
• 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