PANTHER SYSTEM, CONTINUOUS FLUID AND WASTE
Received May 28, 2026 · Event occurred May 7, 2026
Report 2024800-2026-00025 · MDR key 25325959
Device
Generic name
Instrumentation For Clinical Multiplex Test Systems
Manufacturer
Hologic, Inc.Catalog number
PRD-05490
Product problems
- Sharp Edges
Patient
NA · Unknown
- Skin Tears
Narrative
Additional Manufacturer Narrative
HOLOGIC FIELD SERVICE ENGINEER REMOVED THE ZIP TIE AND PROVIDED PHOTOGRAPHS OF THE INJURED HAND AND THE PLACEMENT OF THE ZIP TIE WITHIN THE WASTE DRAWER. HOLOGIC PERFORMED A PREVIOUS EVENT SEARCH AND RISK ASSESSMENT. BASED ON THE AVAILABLE INFORMATION, THIS IS AN ISOLATED INCIDENT. THERE IS NO PATIENT IMPACT AND NO PRODUCT IMPACT. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE OUTCOMES RELATED TO THIS EVENT.
Description of Event or Problem
ON MAY 7, 2026, HOLOGIC FIELD SERVICE ENGINEER (FSE) REPORTED ON BEHALF OF A CUSTOMER IN THE UNITED STATES, THAT A PANTHER OPERATOR CUT THEIR HAND ON A ZIP TIE WHILE CHANGING THE SOLID WASTE BAG ON THE PANTHER PLUS INSTRUMENT. IT WAS NOTED THAT THE INJURED OPERATOR WAS WEARING A GLOVE AT THE TIME OF THE INCIDENT. THE INJURED OPERATOR¿S HAND WAS TREATED ONSITE WITH ANTIBACTERIAL SOAP AND THE OPERATOR WAS ABLE TO RETURN TO WORK. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE OUTCOMES RELATED TO THIS EVENT.