Laparoscope, Gynecologic (and Accessories)

Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE

Inadequate reprocessing validation evidence

Olympus ENDOEYE HD II Rigid Videoscope

Reports of a pink or green coloration of the image. If the issue is encountered during a procedure, device exchange could potentially result in prolonged surgery; potential visual impacts mucosal injury or bleeding may occur.

OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter)

Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for the proper reprocessing of these videoscopes

OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter)

Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for the proper reprocessing of these videoscopes

Injection Needle, LUER-lock,0.8mm, REF: 26175PD

The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.

Olympus ENDOEYE HD II Video Telescopes

A damaged temperature sensor at the endoscope's tip can cause the endoscope's distal end to become abnormally hot.

Olympus ENDOEYE HD II Video Telescopes. Models WA50040A ENDOEYE HD II, 10 mm, 0 degree, WA50042A ENDOEYE HD II 10 mm, 30 degree, W7100603 Repair cable 10 mm 0/

A damaged temperature sensor at the ENDOEYE tip caused the distal end to become abnormally hot. Excessive heating of the ENDOEYE distal end could result in patient or user injury.

Instructions for Use for the blue endo MOREsolution Electromechanical Laparoscopic Morcellator System, Model 55-000011, consisting of the control unit, hand-gri

Some pages of the Instructions for Use were omitted, including pages regarding the Indications for Use, Warning, and Contraindications.

Gynecare Morcellex Tissue Morcellator;

There is the potential for the duckbill seal to become dislodged.

Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.

Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric component inside the 15mm trocar can stretch into a configuration that blocks the flow of insufflation gas (C02).