Olympus previously introduced an annual TJF-Q180V inspection program whereby users are asked to return the TJF-Q180Vs in their possession for inspection. Olympus has reviewed the data obtained via this program and has observed deterioration of the TJF-Q180V's distal end adhesive. The probability of damage to or deterioration of the TJF-Q180V increases with the number of procedures performed and/or the increase in the total operating hours and/or reprocessing chemical damage. Continued use of a TJF-Q180V with adhesive deterioration or other damages may pose a risk of endoscope contamination due to ineffective reprocessing or fluid invasion. A contaminated endoscope can present an infection risk to patients. The instructions for use (IFU) that accompany each TJF-Q180V duodenoscope distributed by Olympus instruct the persons in charge of medical equipment maintenance in each hospital to inspect the device periodically in addition to the inspection required before each patient procedure. In an effort to aid and assist our customers in conducting TJF-Q180V inspections, Olympus will distribute an illustrated checklist to supplement the operation and reprocessing manuals. The checklist contains reference photos showing TJF-Q180V deteriorations and damages to aid users in identifying when an endoscope requires repair prior to clinical use. Recall start date: 2021-11-19
RecallTracker