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Health Canada Medical devices

HALO PKS Cutting Forceps

Issued February 1, 2024
Issue
Olympus has received eighteen (18) complaints for this issue, and sixteen (16) of these complaints were reported as serious injuries. The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure. Through our investigation, Olympus has determined that the issue impacts lots manufactured between March 2022 to December 2023. Recall Start Date: January 19, 2024
Hazard description
Performance
Product
Product name
HALO PKS Cutting Forceps
Reference
ID
RA-74987