MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH BIPOLAR APPLICATOR "CELONPROBREATH", US; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	WB990310
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
Event or Problem Description
It was reported by an olympus territory manager, the patient's turbinate was being overtreated during a submucosal resection (smr) procedure using the electrosurgical generator.It was reported the output from the handpiece was high and the tissue experienced necrosis.The customer was advised to turn down the output of 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.Follow-up with the physician indicated the necrosis issue was noted at the first follow-up appointment after the smr 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: wa90002a, serial (b)(4), and wb990310, lot 1000084723.The 3 patients involved and the corresponding devices are as follows: case with patient identifier (b)(6) reports 75 year old asian male, wa90002a, case with patient identifier (b)(6) reports 75 year old asian male, wb990310, case with patient identifier (b)(6) reports 49 year old asian male, wa90002a, case with patient identifier (b)(6) reports 49 year old asian male, wb990310, case with patient identifier (b)(6) reports 52 year old white female, wa90002a, case with patient identifier (b)(6) reports 52 year old white female, wb990310.
Additional Manufacturer Narrative
The device referenced in this report has not been returned to olympus for evaluation.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 - 00051.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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, the cause of the reported event is most likely due to the incorrect setting of the generator.Furthermore, the cause is also likely attributed to insufficient knowledge regarding the usage of the device.Olympus will continue to monitor field performance for this device.

• Brand Name: BIPOLAR APPLICATOR "CELONPROBREATH", US
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: 15414418
• Report Number: 9610773-2022-00394
• Device Sequence Number: 12140554
• Product Code: GEI
• UDI-Device Identifier: 14042761083529
• UDI-Public: 14042761083529
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K032838
• 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): 09/30/2022

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: WB990310
• Device Catalogue Number: WB990310
• Device Lot Number: 1000084723
• 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: 08/24/2022
• Supplement Date Received by Manufacturer: 09/19/2022
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: WA90002A, SERIAL (B)(6).
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Race: Asian