Other Medical Devices

Real-time shelf life testing failed at 24 months

The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility.

One lot of product was distributed in unsealed packaging

Inside the packaging of one reported item a non-conforming product was found. Contrary to the design, the barrier layer was manufactured on the inferior side of the implant versus the superior side.

Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray radiation dose rate in fluoroscopic mode.

Tile kits that allow one to install and situate a video camera within a patient environment are not fitting properly in some domestic institution ceiling tile grids that have a thinner style grid frame. The ceiling tile may suddenly fall from the ceiling and cause a safety risk to the patient or end user.

Due to 16 complaints related to drivers not engaging in implants. According to the firm's investigations, the incorrect offset gauge was potentially used during production of the implants. As a result, this could potentially lead to aborted or a delay in surgical procedure.

Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery

Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs.

Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery

Product stored incorrectly in temperature controlled setting instead of refrigeration.

Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand switch is not used or if the wired foot switch is not connected to the system.

Missing bushing on Liko M220 and M230 causing wear and potential for patient falling

There is a potential for the outer Tyvek lid to de-bond from the sealed package.

Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin

There is potential for separation between the threaded hub and threaded cap at the proximal end of the device.

Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand switch is not used or if the wired foot switch is not connected to the system.

Incorrect marketing label (25 mm) was applied to product size 20 mm.

There is a potential for the outer Tyvek lid to de-bond from the sealed package.

Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin