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.
FDA Recall Z-0747-2012 · Posted 2012-01-13
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Recalling FirmOlympus America Inc.
Recall StatusTerminated
Product CodeGEI
Date Initiated2011-11-28
Date Terminated2013-03-01
Product Quantity245
Reason for Recall
Investigations of customer complaints revealed a counterfeit capacitor was used in the manufacture of some lots of the ESG-100.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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