Single Use Repositionable Clip

Olympus has become aware of increased complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include reports that: 1) the clip arm does not open when the user pushes the slider, 2) the clip arm does not close when the user pulls the slider and 3) the clip detaches from the target tissue earlier than expected, after being deployed in a procedure.

The issues described above can lead to hazardous situations in which the clips cannot achieve their intended purpose, namely: (1) approximate a tissue opening or defect, (2) provide hemostasis to a bleeding vessel or mucosa, or (3) serve as a marker for subsequent location identification. Patient harms associated with these hazardous situations include: absence of treatment (e.g. hemostasis not achieved), prolonged procedure (e.g. extended time to accomplish hemostasis), and unexpected medical interventions (e.g. additional clipping) being required to accomplish therapeutic purposes. Additionally, the issues described above can lead to mucosal injury/perforation, hemorrhage, and dehiscence of a previously approximated closure.

Recall start date: May 2, 2023