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

Model Number WA90002A

Device Problem Output above Specifications (1432)

Patient Problem Necrosis (1971)

Event Date 06/10/2022

Event Type  Injury  

Event 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 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).

• Brand Name: ELECTROSURGICAL GENERATOR "CELON ELITE ESG-200", B TYPE
• Type of Device: ELECTROSURGICAL SYSTEM GENERATOR
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 15288646
• MDR Text Key: 298566557
• Report Number: 2429304-2022-00037
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042761082969
• UDI-Public: 04042761082969
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/27/2022,09/13/2022

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
• Device Operator: 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?: Yes
• Distributor Facility Aware Date: 07/27/2022
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/27/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/13/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other