Electrode, Electrosurgical, Active, Urological

ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loop Electrode Stabilized, 0.012 Wire 24 Fr

Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes.

HF Resection Electrodes - HF resection electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in urological or gynecological applic

Additional Caution statements in IFU: (1) Due to complaints where the loop wire at the distal end of the HF resection electrode broke after getting in contact with metal objects, such as other endoscopic equipment, implants or stents. As a result, fragments can fall inside the patient and must be retrieved. (2) The second Caution refers to the risk of sparkover when getting in contact with metal parts as this can cause uncontrolled heating of the HF-resection electrode and may result in damage and breakage to the HF-resection electrode tip

C-Max" Cutting Loop Electrodes, Storz One-Stem, 24 Fr, .014in., .35 mm, Sterile, Rx only, Manufactured by: C.R. Bard, Inc., Covington, GA 30014.

Defect; The contact part could possibly separate from the electrode affecting to functionality of the device.

HF Cable WA00014A, Endoscopic electrosurgical unit and accessories

Software malfunction that results in incorrect generation or display of error codes.

SD-230U-20 ELECTROSURGICAL SNARE, model no. SD-230U-20 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

SD-240U-10 ELECTROSURGICAL SNARE, model no. SD-240U-10 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

SD-240U-15 ELECTROSURGICAL SNARE, model no. SD-240U-15 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

SD-240U-25 ELECTROSURGICAL SNARE, model no. SD-240U-25 - Product Usage: Used with endoscopes to electrosurgically resect tissue within the digestive tract.

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-129A (00821925008700)

There is a potential for the cord to spark and cause a fire.