Surgical Instruments

Outer carton packaging of microcatheters were exposed to wet substance during transport.

The product falls apart during handling after removal from its primary packaging.

Complaints received in which needle and needle holder have detached from the syringe after injection as well as needle not retracting into the syringe as per intended use, resulting in an increased risk of needle stick injury to the end user

Complaints received in which needle and needle holder have detached from the syringe after injection as well as needle not retracting into the syringe as per intended use, resulting in an increased risk of needle stick injury to the end user

Due to preventative maintenance (PM) not being performed on E-100 generators which is a bipolar electrosugical unit designed to be used with the da Vinci Xi and X systems.

Devices were subject to unapproved rework processes.

Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" as reflected on the product outer packaging.

There is a potential for the core diameter to be undersized, which may lead to the router breaking. A break can lead to unintended metal fragments in the surgical site, resulting in the potential for surgical intervention or damage to critical neurological or vascular structures.

BD Intraosseous Needle Kits may exhibit: 1) Increased force required to remove the stylet from intraosseous needle during placement may cause removal of the entire needle assembly and loss of intraosseous access; 2) Stylet safety mechanism may not engage as the stylet is removed; 3) Metal discs in the powered driver may stick rendering the driver unusable.

When scanning sponges out after a surgical procedure, an error may allow for a duplicate sponge to be counted without the prompt to make a case note and allowing the case to close. The software update will prevent the occurrence of this error.

Firm has revised labeling to consistently call out storage conditions and revised the instructions for use to clarify that the temperature range symbol is intended to indicate storage conditions (versus transport conditions or tolerance conditions for the package material).

Set screwdriver fails during surgery by deforming at the tip during engagement and manipulation of the implant.

Customized coronal rod benders may deform the implant when used with the spinal system devices.

Customized coronal rod benders may deform the implant when used with the spinal system devices.

Due to latex gloves being include in Custom Pak. Kits are supposed to include non-latex gloves.

Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM.

There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.