Other Medical Devices

AI-powered bacterial culture plate interpretation and workup software does not have Premarket Approval or pre-market notification (510(k)/de novo), so there is potential risk that the colony count and/or morphology information from images may not accurately reflect actual plate and may lead to inaccurate counts and/or morphology characteristics impacting patient diagnosis and subsequent care.

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. If lockout occurs, the device will momentarily activate but will not cut or staple tissue, and additional steps will be required to open it and remove it from tissue. If user is unable to remove the device from the tissue, potential harms to patient include surgical delay, bleeding/hemorrhage, life threatening hemorrhage/hemorrhagic shock, and conversion to open therapy. Two adverse events received, including one patient death.

Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.

Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

With certain software versions, import of enhanced ultrasound formatted data/ultrasound images into 3D viewer, (for digital image processing/review/analysis/communication/media interchange acquired from CT/MRI/ultrasound, and pre-operative analysis of surgical options), can result in incorrect display of image orientation, which could result in misdiagnosis or incorrect surgical treatment plan.