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Medtronic SenSight Tunneler Kit (Medtronic) – carrier machining issue (2023)

Medtronic has received reports of SenSight Extension Tunneler kits that contain dual carriers with have been machined on only one side. As a result, the dual carrier cannot be used to pass two extensions simultaneously.

Moderate

FDAMar 17, 2023Nationwide• Medtronic Neuromodulation

Spectral CT 7500 System (Philips) – foot switch entrapment (2023)

Laceration Risk

Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operators foot. If foot or leg entrapment occurs while pressing Unload Pedal, the risk to operators may include: pain, muscle or ligament sprain, abrasion, laceration, contusion, fracture, loss of function, and joint dislocation.

High

FDA

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Medtronic SenSight Tunneler Kit (Medtronic) – carrier machining issue (2023)

Spectral CT 7500 System (Philips) – foot switch entrapment (2023)

Steris Light Handle Cover (Steris) – detachment risk (2023)

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Integre Pro Laser Device (Ellex) – beam scattering risk (2023)

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Stryker MAKO Baseplate Trial (Howmedica) – incorrect size marking (2023)

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Alcon Custom Pak Surgical Pack (Alcon) – Incomplete Seals (2023)