MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH BERLIN FACILITY ELECTROSURGICAL GENERATOR "CELON ELITE ESG-200", E-TYPE; HF-GENERATORS

Model Number	WA90001A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Olympus was informed that during a therapeutic turbinectomy procedure at an unknown date the esg-200 hf generator issued message e0689 (instrument wearout note: the instrument is about to reach its maximum usage time.Replace the instrument if possible).The olympus bipolar applicator "celonprobreath" (wb990007), which was used during the procedure is not marketed in the us.The intended procedure was completed using the same set of equipment.During a post-operative examination a few days later, scabs were observed in the patient.Since the scabs have become infected, the patient is being treated with antibiotics.No further information was provided.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for inspection, and the customer¿s reported failure was confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been less than 1 year since the subject device was manufactured.Based on the results of the investigation, error e0689 is displayed when the number of permitted activations of the bipolar instrument will be reached soon.Possible causes for error e0689 are: 1.The number of permitted activations of the bipolar instrument will soon be exceeded.2.The rfid chip in the instrument is defective (which can be caused by gamma rays during sterilization).In addition, error e0690 is displayed when the number of permitted activations of the bipolar instrument is exceeded.Possible causes for error e0690 are: 1.The number of permitted activations of the bipolar instrument has exceeded.2.The rfid chip in the instrument is defective (which can be caused by gamma rays during sterilization).Both errors e0689 and e0690 are warnings for the user to change the instrument soon.Neither a technical defect nor a user error caused these error messages.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿a suitable replacement device must be provided during an application.¿ this supplemental report includes new information received from the customer that was not previously reported.The information has been added to e1.A correction has been made to a1 and g2 to provide information that was inadvertently not included on the initial medwatch.New information has been added to d8, d9 and d10.Also, an update has been made to h3.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is (b)(4).

• Brand Name: ELECTROSURGICAL GENERATOR "CELON ELITE ESG-200", E-TYPE
• Common Device Name: HF-GENERATORS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH BERLIN FACILITY; rheinstrasse 8; teltow, brandenburg 14513 ; GM 14513
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH BERLIN FACILITY; rheinstrasse 8; teltow, brandenburg 14513 ; GM 14513
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662955
• MDR Report Key: 15823952
• Report Number: 9610773-2022-00546
• Device Sequence Number: 12263158
• Product Code: GEI
• UDI-Device Identifier: 04042761082952
• UDI-Public: 04042761082952
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Other,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/21/2024

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: WA90001A
• Device Catalogue Number: WA90001A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2022
• Supplement Date Received by Manufacturer: 12/14/2022; 06/21/2024
• Initial Report FDA Received Date: 11/18/2022
• Supplement Report FDA Received Date: 04/11/2023; 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS APPLICATOR "CELONPROBREATH" (WB990007).; WA00014A.; WA22367A.; WA22557C.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown