Jun

2021

FDA Recall: Injury Resulting from Exceeding Standard Presets

Company: Olympus Corporation of the Americas
Date of Enforcement Report: June 30, 2021
Class II

PRODUCT

Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in urology, lithotripsy, gastroenterological surgery and gynecological surgery.

Recall Number:

Z-2294-2021

REASON:

Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded the 20W standard presets.

RECALLING FIRM/MANUFACTURER:

Olympus Corporation of the Americas

VOLUME OF PRODUCT IN COMMERCE:

408 units

DISTRIBUTION:

US Nationwide Distribution Foreign: Canada Australia Japan Hong Kong Europe Singapore

About the author

Allison Pate

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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FDA Recall: Injury Resulting from Exceeding Standard Presets

Allison Pate

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