MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH ELECTROSURGICAL GENERATOR "CELON ELITE ESG-200", B TYPE; ELECTROSURGICAL SYSTEM GENERATOR

Model Number	WA90002A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Necrosis (1971)
Date of Event	06/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report has not yet been received by olympus for evaluation (although it is anticipated).The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.This event has been reported by the importer on mdr#2429304 - 2022 - 00037.
Event or Problem Description
It was reported by an olympus territory manager, the patient's turbinate was being overtreated during a submucosal resection procedure using the electrosurgical generator.It was reported the output from the handpiece was high and tissue was experiencing necrosis.The customer was advised to turn down the output of the device.The olympus representative plans to provide the customer with an additional in-service on operating the device.The procedure was completed without delay, and there were no reports of a device malfunction.It was reported the device was inspected prior to the procedure, and no anomalies were found.Additional details have been requested regarding the reported event.
Event or Problem Description
Additional information was received from the customer: the physician stated the device did not malfunction.The issue was noted at the first follow-up appointment after the submucosal resection procedure.The physician reported three (3) patients experienced necrosis of the head and mid-body of the inferior turbinate.There were allegedly no clinical symptoms, but the physician had a concern for long term empty nose syndrome.The tissue necrosis was treated with debridement and observation.The physician reported 2 devices were involved with the event: (b)(6) serial (b)(6) lot 1000084723.The 3 patients involved and the corresponding devices are as follows: (b)(6).
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer¿s investigation and the results of the device history record (dhr) review.New information was added to the following fields: b3, b5, h6, h10.The dhr for this device was reviewed and all records indicated the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.A definitive root cause was not identified and the product was not returned to olympus.Based on the available information, the legal manufacturer determined the probable cause of the reported issue is likely due to user error.Olympus will continue to monitor the field performance of the device.

• Brand Name: ELECTROSURGICAL GENERATOR "CELON ELITE ESG-200", B TYPE
• Common Device Name: ELECTROSURGICAL SYSTEM GENERATOR
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662955
• MDR Report Key: 15288709
• Report Number: 9610773-2022-00342
• Device Sequence Number: 2468017
• Product Code: GEI
• UDI-Device Identifier: 04042761082969
• UDI-Public: 04042761082969
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: WA90002A
• Device Catalogue Number: WA90002A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2022
• Supplement Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 08/24/2022
• Supplement Report FDA Received Date: 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown