Tourniquet, Pneumatic（KCY）

Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.

Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.

Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the cuff not being able to maintain pressure.

Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Issue may cause delay or extension while alternate device is located.

Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Issue may cause delay or extension while alternate device is located.

Tourniquet cuff flange may become detached from the bladder. If leak occurs during the procedure, there may be risk of hemorrhage, resulting in blood loss greater than expected. Other serious risks include cerebral hypotension and cardiovascular collapse and arrest, risking stroke or death. Specific to IVRA, patient toxicity may also occur due to rapid systemic absorption of anesthetics.

Mislabeling; tourniquet cuff packaging labeled as dual port single bladder but contains a tourniquet cuff single port single bladder.

Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood loss, hemorrhage or, in exceedingly rare situations, other major complications

Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood loss, hemorrhage or, in exceedingly rare situations, other major complications

Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood loss, hemorrhage or, in exceedingly rare situations, other major complications

Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood loss, hemorrhage or, in exceedingly rare situations, other major complications

Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood loss, hemorrhage or, in exceedingly rare situations, other major complications

Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood loss, hemorrhage or, in exceedingly rare situations, other major complications

Increased incidence of disposable tourniquet cuffs "not able to achieve desired pressure" and "not holding pressure" due to 1) Cuff fabric tearing during use, and 2) Pinched or unseated O-ring at the connection between the cuff, disposable fill line, and/or cuff hosing, which may lead to loss of vascular occlusion, which may lead to operative site blood loss, hemorrhage, or other complications.

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

When inflating/deflating a single bladder, both bladders could potentially inflate/deflate due to a leak between the bladders.

There is a potential for the cuff to leak air leading to a loss of vascular occlusion.

There is a potential for the cuff to leak air leading to a loss of vascular occlusion.

Tourniquet cuffs are potentially mislabeled. If used may lead to (1) Device misuse during procedure (2) Inadequate Limb Compression Force.

Delfi Medical Innovations Inc has discovered that tourniquets cuffs in certain lots of the VariFit Sterile Single Use Thigh Cuffs, Single Port, Single Bladder models may have been manufactured with an inadequate perimeter weld on the cuff. Once applied to a patients thigh and inflated to a pressure to occlude blood flow in the thigh distal to the cuff, after a period of time the cuff may leak to the extent that the tourniquet instrument supplying air pressure to the cuff may not be able to adequately control and regulate pressure in the cuff. This may result in some blood flow in the thigh distal to the cuff.