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n.a.

Karl Storz GmbH & Co. KG · Model 27077A · UDI-DI 04048551079478

LQC Prescription

510(k) clearances

2,901

Adverse events (12 deaths)

Recalls

Facilities

Description

Punch Working Element

Recalls

Date	Firm	Reason
2024-12-16	Olympus Corporation of the Americas	Potential for distal tip tearing of the Mechanical Lithotriptor V.
2021-01-04	Aomori Olympus Co., Ltd.	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.
2021-01-04	Aomori Olympus Co., Ltd.	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.
2007-09-20	Olympus America Inc.	Slider knob does not move smoothly causing the user difficulty in advancing the coil sheath
2007-09-20	Olympus America Inc.	Slider knob does not move smoothly causing the user difficulty in advancing the coil sheath
2007-09-20	Olympus America Inc.	Slider knob does not move smoothly causing the user difficulty in advancing the coil sheath
2007-09-20	Olympus America Inc.	Slider knob does not move smoothly causing the user difficulty in advancing the coil sheath

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.