—#196521

Product

GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform cutting and/or coagulation and coagulation with or without delivery of argon gas, in flexible endoscopic applications. MODEL #(s): G1110001

FDA product code: GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K192265
Affected lot / code info: UDI: 00724995180256 Serial Numbers: 0032-0822-003, 0032-0622-009, 0032-0922-001, 0032-0822-001, and 0032-0082-002

Why it was recalled

Two electronic diode components (D1 & D4) placed in the reverse orientation on the controller printed circuit board assembly may result in premature wear of the power regulator, leading to the regulators failure which could cause a full power loss. If the regulator failure were to occur during a patient procedure, a procedural delay may result

Root cause (FDA determination)

Component design/selection

Action the firm took

STERIS issued Urgent Medical Device Field Correction on 10/17/22. Letter states reason for recall, health risk and action to take: All affected Customers will be contacted by a STERIS Representative to arrange the return of their GI4000 Electrosurgical Units to complete the correction. User Action Please ensure the following steps are completed: 1. Work with STERIS Representative to arrange pick up of your GI4000 Electrosurgical Unit. 2. STERIS will repair or replace the GI4000 Electrosurgical Unit for your facility. If you have questions regarding this matter, please contact Jennifer Bailey, Product Manager at 440-358-6075 or your local STERIS Representative will provide Customer Notification Letters to all Customers who purchased affected GI4000 Electrosurgical Units. STERIS will request that all affected GI4000 Electrosurgical Units be returned to complete the correction. While the units are being reworked, Customers will be provided with a loaner unit. Cintron Medical will be changing the receiving inspection plan for the PCBA. The inspection plan will have a step to verify the orientation of the diodes.

Recalling firm

Firm: Steris Corporation
Address: 5960 Heisley Rd, Mentor, Ohio 44060-1834

Distribution

Distribution pattern: US Nationwide distribution in the states of Arizona, Illinois, Tennessee, Virginia.

Timeline

Recall initiated: 2022-10-17
Posted by FDA: 2022-11-16
Terminated: 2024-05-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #196521. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.