Olympus Corporation of the Americas is recalling 50,040 units of the ENDOEYE HD II Rigid Videoscope, models WA50040A and WA50042A, due to reports of pink or green tints appearing in the camera image. This defect can occur during surgical procedures within the thoracic and abdominal cavities. If the image quality fails during surgery, the device must be exchanged, which could lead to prolonged operative time, mucosal injury, or bleeding for the patient. Consumers should contact their healthcare provider or Olympus for guidance on affected units.
The camera system may display a pink or green coloration that distorts the surgical view, potentially causing a surgeon to inadvertently cause mucosal injury or bleeding. Furthermore, the need to swap devices mid-procedure can dangerously prolong the time a patient is under anesthesia.
Manufacturer Notification and Device Exchange/Inspection
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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