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ELRA Electrode

STARMED CO.,LTD · Model 7-4B18S · UDI-DI 08809306762382

KNS Prescription

510(k) clearances

17,476

Adverse events (81 deaths)

125

Recalls

118

Facilities

Description

The ELRA Electrode is a bipolar electrode. The ELRA Electrode is a sterile, single-use electrosurgical accessory intended to be used in conjunction with VIVA combo RF generator (K163450). They are not intended to function with other RF generators. The ELRA Electrode consists of an electrode tip, insulation part, handle. Patient contacting materials of ELRA Electrode are stainless steel 304, Teflon-ETFE, UV adhesive, Nylon, PEEK and polyether block amides.

Recalls

Date	Firm	Reason
2026-08-19	Olympus Corporation of the Americas	Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
2026-08-19	Olympus Corporation of the Americas	Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
2026-08-19	Olympus Corporation of the Americas	Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
2026-08-19	Olympus Corporation of the Americas	Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.
2026-01-07	Olympus Corporation of the Americas	Devices which did not undergo thermoforming could deform and lose performance.

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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.