Stapler, Surgical

PROXIMATE Skin Stapler. PROXIMATE RH Rotating-Head Skin Stapler (Model PRR35), PROXIMATE PX Fixed-Head Skin Stapler (Model PXR35), Bulk/Non-Sterile PROXIMAT

The device may have a non-conforming component that may cause the device to fire an unformed staple.

-ENDOPATH ETS-Flex Articulating Endoscopic Linear Cutter, (Blue) w/o Staples 35mm. REF ATB35 Lot 122300.

The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

PSX PROXIMATE Skin Staple Extractor,

Damage to the packaging may have compromised the sterility of the device.

Disposable Skin Stapler - 35 Wide; Surgical Skin Stapler; Rx, sterile, single use skin stapler, individually packaged in a thermo-formed tray with a Tyvek lid,

The sterility of the staplers is questionable.

SurgASSIST System. Circular Stapler DLU 29 mm (product code CS29)

latching mechanism failure

SurgASSIST System. Circular Stapler DLU 33 mm (product code CS33).

latching mechanism failure

EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28XT TRIEEA31MT TRIEEA31XT

The firm identified the potential for a device to have an incorrect tissue gap. Use of a device with an incorrect tissue gap may result in incomplete staple formation and/or the inability to remove the device from tissue following application potentially leading to bleeding, anastomotic leak or tissue trauma. There have been no reports of serious injury related to this issue.

EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbers EEA25, EEAXL25, EEA2535, and EEAXL2535.

The affected staplers have the potential for the staple guide to not be securely attached to the instrument. The issue could cause the component to disengage and if disengaged, could allow the device to transect tissue without forming staples.

daVinci XI Sureform 60 reload, 60 mm Green 6- Row, 4.6 mm, REF 48360G-08, UDI: 00886874113844, Rx Only, Sterile EO - Product Usage: are intended to be used wit

The firm became aware of a manufacturing variation in which black and green reloads in select Stapler Reloads may not deploy individual adjacent staples, which could result in an incomplete staple line. Failure of a incomplete staple like could potentially lead to an air leak or an anastomotic leak which may require an additional procedural intervention.

daVinci XI Sureform 60 Reload, 60 mm black 6-Row 4.6 mm, Ref: 48360T-08 , UDI: 00886874113851, Rx only, SterileEO - Product Usage: are intended to be used with

The firm became aware of a manufacturing variation in which black and green reloads in select Stapler Reloads may not deploy individual adjacent staples, which could result in an incomplete staple line. Failure of a incomplete staple like could potentially lead to an air leak or an anastomotic leak which may require an additional procedural intervention.