Class 2 Device Recall Olympus Electrosurgical Unit (ESG100)

• Date Initiated by Firm: November 28, 2011
• Date Posted: January 13, 2012
• Recall Status: Terminated on March 01, 2013
• Recall Number: Z-0747-2012
• Recall Event ID: 60548
• 510(K)Number: K073207
• Product Classification: Electrosurgical, cutting & coagulation & accessories - Product Code GEI
• Product: Olympus Electrosurgical Unit. The Olympus Electrosurgical Unit (ESG-100) is used in conjunction with cutting and coagulation electrosurgical devices intended for use in electrosurgery procedures during flexible gastrointestinal endoscopy.
• Code Information: Serial numbers 11053P230001, 11053P230002, 11053P230003, 11053P230004, 11053P230005, 11060P230001, 11160P230002, 11060P230003, 11160P230004, 11160P230005, 11081P230001, 11081P230003, 11081P230004, 11081P230005, 11081P230006, 11081P230007, 11081P230008, 11081P230009, 11081P230010, 11094P230006, 11094P230007, 11094P230008, 11094P230009, 11094P230010, 11096P230007, 11096P230008, 11096P230009, 11096P230010, 11102P230001, 11102P230002, 11102P230003, 11102P230004, 11102P230005, 11109P230002, 11109P230003, 11109P230004, 11109P230005, 11110P230001, 11110P230002, 11110P230003, 11110P230004, 11110P230005, 11116P230001, 11116P230002, 11116P230003, 11116P230004, 11116P230005, 11117P230001, 11117P230002, 11117P230003, 11117P230004, 11117P230005, 11132P230001, 11132P230002, 11132P230003, 11132P230004, 11132P230005, 11133P230001, 11133P230002, 11133P230003, 11138P230002, 11138P230003, 11138P230004, 11139P230001, 11139P230002, 11139P230005, 11167P230001, 11167P230004, 11180P230003, 11180P230005, 11201P230005, 11201P230010, 11202P230001, 11202P230005, 25456W23-101, 25456W23-102, 25456W23-107, 25456W23-108, 25456W23-109, 25522W23-101, 25522W23-102, 25522W23-103, 25522W23-104, 25522W23-105, 25553W23-105, 25553W23-107, 25553W23-108, 25553W23-109, 25553W23-110, 25565W23-102, 25565W23-103, 25565W23-105, 25565W23-106, 25565W23-108, 25565W23-109, 25565W23-110, 25593W23-101, 25593W23-102, 25593W23-103, 25593W23-104, 25593W23-105, 25593W23-107, 25593W23-109, 25593W23-110, 25607W23-101, 25607W23-102, 25607W23-103, 25607W23-104, 25607W23-105, 25607W23-106, 25607W23-107, 25607W23-108, 25607W23-110, 25613W23-101, 25613W23-102, 25613W23-103, 25613W23-104, 25613W23-105, 25613W23-106, 25613W23-107, 25613W23-108, 25613W23-109, 25613W23-110, 25686W23-102, 25719W23-105, 25719W23-106, 25736W23-101, 25736W23-102, 25736W23-103, 25736W23-104, 25736W23-105, 25736W23-106, 25736W23-107, 25736W23-108, 25736W23-109, 25752W23-101, 25752W23-102, 25752W23-103, 25752W23-104, 25752W23-105, 25752W23-106, 25752W23-107, 25776W23-101, 25776W23-102, 25776W23-103, 25776W23-105, 25776W23-106, 25776W23-107, 25776W23-108, 25776W23-109, 25776W23-110, 25869W23-101, 25869W23-102, 25869W23-103, 25869W23-104, 25869W23-105, 25869W23-106, 25869W23-107, 25869W23-108, 25869W23-109, 25869W23-110, 25978W23-104, 25978W23-105, 25978W23-106, 25978W23-107, 26052W23-109, 26052W23-110, 26085W23-101, 26085W23-102, 26085W23-103, 26085W23-104, 26085W23-105, 26085W23-106, 26085W23-107, 26085W23-108, 26085W23-109, 26136W23-101, 26136W23-103, 26136W23-104, 26136W23-105, 26136W23-107, 26136W23-108, 26136W23-109, 26136W23-110, 26162W23-108, 26162W23-109, 26162W23-110, 26227W23-102, 26227W23-103, 26227W23-104, 26227W23-105, 26227W23-106, 26227W23-107, 26227W23-108, 26227W23-109, 26227W23-110, 26456W23-101, 26456W23-102, 26456W23-103, 26456W23-104, 26456W23-105, 26456W23-106, 26456W23-107, 26456W23-108, 26456W23-109, 26456W23-110, 26559W23-101, 26559W23-103, 26559W23-104, 26559W23-105, 26559W23-108, 26559W23-109, 26559W23-110, 26710W23-108, 26710W23-109, 26770W23-101, 26770W23-102, 26770W23-103, 26770W23-104, 26770W23-105, 26770W23-106, 26770W23-107, 26770W23-108, 26770W23-109, 26770W23-110, 26878W23-101, 26878W23-102, 26878W23-103, 26878W23-104, 26878W23-105, 26879W23-102, 26879W23-103, 26879W23-104, 26879W23-105, 26917W23-101, 26917W23-102, 26917W23-103, 26917W23-105, 26917W23-106, 26917W23-107, 26917W23-108, 26917W23-109, 26917W23-110, and 26992W23-110.
• Recalling Firm/ Manufacturer: Olympus America Inc.; 3500 Corporate Pkwy.; P.O. Box 610; Center Valley PA 18034-0610
• For Additional Information Contact: Laura Storms-Tyler; 484-896-5688
• Manufacturer Reason for Recall: Investigations of customer complaints revealed a counterfeit capacitor was used in the manufacture of some lots of the ESG-100.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Olympus America Inc. sent an URGENT: MEDICAL DEVICE CORRECTION ACTION" letter dated November 28, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use of the affected product. A questionnaire was attached to the letter for customers to complete and return via fax at 484-896-7128. Contact the firm at 484-896-5000 for questions regarding this notice.
• Quantity in Commerce: 245
• Distribution: Nationwide Distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GEI