MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH CELON ELITE ESG-200, E; HF-GENERATORS

Model Number	WA90001A
Medical Device Problem Codes	Output Problem (3005); Activation Problem (4042)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus was informed that during a therapeutic procedure to treat hypertrophic turbinates, the hf-generator esg-200 could not be activated.The patient had already being anesthetized when the device failure was noticed resulting in the procedure being cancelled as the issue could not be resolved.No further information was provided.
Additional Manufacturer Narrative
The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the patient's outcome and the reported phenomenon could not be determined and is being judged as unknown.However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.
Additional Manufacturer Narrative
The suspect medical device was not returned to the manufacturer for investigation/evaluation but to a regional olympus repair center in ireland.The evaluation confirmed the reported output failure and traced it back to a defective motherboard.Thus, the reported incident can be attributed to component failure.A manufacturing and quality control review was performed for the affected serial number of the hf generator without showing any abnormalities.The case will be closed on olympus side with no further actions.The reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation result.

• Brand Name: CELON ELITE ESG-200, E
• Common Device Name: HF-GENERATORS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; rheinstrasse 8; teltow
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662955
• MDR Report Key: 14407000
• Report Number: 9610773-2022-00176
• Device Sequence Number: 20231837
• Product Code: GEI
• UDI-Device Identifier: 04042761082952
• UDI-Public: 04042761082952
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: WA90001A
• Device Catalogue Number: WA90001A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2022
• Supplement Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 05/16/2022
• Supplement Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2016
• 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