Generic Name: Surgical Robot System — Trade Name: Hugo Ras System
Recall Summary Covidien is recalling 14 Hugo RAS surgical robot surgeon consoles due to power supply failures that can cause loss of power to the console during or before surgery. The affected units were shipped between June 2023 and April 2024 and are identified by specific serial numbers. While the system can still be manually operated if power is lost, remote control from the surgeon's console may become impossible, potentially delaying surgery or requiring a switch to another surgical method.
- Recalling firm
- Name of Manufacturer/Distributor: Covidien Japan Co., Ltd. — Address of Manufacturer/Distributor: 1-2-70 Konan, Minato-ku, Tokyo — Type of License: Class I Medical Device Manufacturer/Distributor...
- Product
- Lot: 製品名称 :サージョンコンソール 製品番号 :MRASC0001 対象シリアル： C22AJF0211 C22AJM0294 C22AJM0295 C23AJA0298 C23AJC0344 C23AJF0376 C23AJH0393 C23AJH0395 C23AJH0398 C23AJJ0410 C23AJJ0411 C23AJJ0412 C23AJJ0413 C24AJF0498 出荷数量 ：14 出荷時期 ：令和5年6月22日〜令和7年4月11日. Use: 本品は、泌尿器科、婦人科及び一般消化器外科（肋間からのアプローチを行う術式を除く）の各領域において、 鏡視下手術を実施する際に、組織又は異物の把持、切開、鈍的/鋭的剥離、近置、結紮、高周波電流を用いた切 開・凝固、縫合及び操作、並びに手術付属品の挿入・運搬を行なうために、術者の鏡視下手術器具操作を支援す る装置である。 本品は、成人患者を対象として使用する。. Health hazards: 当該事象が発生した場合、手技の遅れや組織損傷、出血などにつながるおそれがあります。しかしながら、当該 機器は手術にて使用され、当該事象が発生した場合においても医療従事者により異常に気付くことができ、対処 が可能であることから、重篤な健康被害には至らないものと考えられます。...
- Reason
- We have received 25 reports from both domestic and international sources of power supply failures in the power supply components of the Hugo RAS system’s surgeon console, resulting in a loss of power to the console. The affected power supply component provides power to the entire surgeon console, with the exception of the Surgeon 3D Display. In the unlikely event that the power supply component fails, it is possible to manually operate the arm and remove the instruments as necessary; however, remote control of the Hugo RAS system from the surgeon’s console may become impossible. Since this...
- Classification
- Class II
- Category
- medical device recall
- Country
- Japan
- Agency
- PMDA-DEVICE
- Status
- Ongoing
Official recall notice from PMDA-DEVICE
Recall details on Nibble Recalls: https://trynibble.app/recalls/8ce92085-726d-4865-93b4-d8e1cb28996f