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

Catalog Number	902615
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	02/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The procedure to replace the peristaltic tubing does not require opening of the mid-bay drawer.Hologic performed a risk assessment and noted no product impact as the issue was due to hologic personnel not following procedure.Hologic concludes that the incident was caused by a user error (failure to follow instructions and lapse in attention) by hologic mas and operator.Hologic has not been informed of any additional adverse customer outcomes related to this situation.
Event or Problem Description
On february 13th, 2025, a hologic molecular application specialist (mas) reported to hologic that a customer operator got injured whilst replacing the peristaltic tubing on panther instrument serial number (b)(6).While the mas instructed the customer to change the peristaltic tubing, the customer accidentally dropped the clamp inside of the instrument and the instrument¿s mid-bay drawer had to be opened to retrieve the part.When closing the drawer, the customer¿s hand was accidentally pinched.The customer¿s hand was examined by the lab¿s medical staff and a cooling pack was applied.The customer discontinued work for the remainder of the day.Customer returned to work the next day and noted feeling better.Hologic has not been informed of any additional adverse customer outcomes related to this situation.

• 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: 21586663
• Report Number: 2024800-2025-00010
• Device Sequence Number: 8868578
• Product Code: OOI
• UDI-Device Identifier: 15420045504141
• UDI-Public: 15420045504141
• Combination Product (Y/N): N
• Initial Reporter Country: DE
• 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): 03/12/2025

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: 02/13/2025
• Initial Report FDA Received Date: 03/12/2025
• 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