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

Model Number	WB990311
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Necrosis (1971)
Date of Event	11/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report has been received by olympus for evaluation, however the evaluation has not yet been concluded.The definitive cause of the user's experience cannot be determined at this time, 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# 2951238-2021-00447.
Event or Problem Description
The customer reports after a radiofrequency ablation (rfa) of the soft palate using a celon pro sleep plus hand piece, necrosis was found bilaterally on the superior and inferior aspects of the soft palate.The patient experienced pain from the necrosis.There is no obvious velopharyngeal insufficiency (vpi) or nasal regurgitation as of yet.The necrosis was treated with antibiotics and peridex (antiseptic oral rinse).The patient's current condition is described as "improving".
Additional Manufacturer Narrative
This report is being updated to provide investigation findings.New information is reported in h4, h6, and h10.Physical evaluation of new returned devices from the same lot as the suspect device: olympus received one opened box model celonprosleep lot# 1000067470, containing 3 brand new bipolar electrodes.Each item has a handwritten on its packaging, but still in sealed condition.There is no damage on the packaging and all physical devices appeared to be intact, in good condition.One out of three devices was inspected by olympus and found to have no abnormalities in the appearance.The device was then checked with our test generator esg-400 with selected mode bipolar rf coag without rcap, and power setting was set from 10 to 13 w.Observed that the electrode tip would go smoothly into the depth of tissue sample and generated energy output when the footswitch was activated.Also, the acoustic signal could be heard when testing completed.Observed no burnt or charred marks on the electrode tip after testing.Based on evaluation findings, the new electrode is functioning properly.Analysis: the user reported postoperative necrosis that had to be treated with medication.Please note that the probes have been examined and show no malfunction.Additionally, it was reported that the generator did not show any malfunction.It should be mentioned that the probes comply with the product standard.Cause: according to our investigators, the cause of the reported issue is most likely due to improper handling.Additional information: the formation of necrosis is solely related to the setting of the generator adjusted by the user and the positioning of the applicator.For example, a low power setting of the generator leads to a larger coagulation volume and a longer application time.Risk analysis: the risk to patients, users, and/or third parties associated with the reported issue was evaluated as acceptable.In general, the customer is required to check the function of all devices used prior to a procedure.Additionally, according to the instructions for use (ifu(, a suitable replacement device must be provided during an application.Device history review (dhr) review: a manufacturing and quality control review was performed for device wb990311 with lot number 1000067470.There is no non-conformity associated with this device with respect to the described issue.The dhr review showed that the device was manufactured according to valid instructions and met all specifications.

• Brand Name: BIPOLAR APPLICATOR "CELONPROSLEEPPLUS", US
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDO
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662955
• MDR Report Key: 12972363
• Report Number: 9610773-2021-00352
• Device Sequence Number: 4331941
• Product Code: GEI
• UDI-Device Identifier: 14042761083536
• UDI-Public: 14042761083536
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 04/15/2022

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: WB990311
• Device Catalogue Number: WB990311
• Device Lot Number: 1000067470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2021
• 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: 11/15/2021
• Supplement Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 12/09/2021
• Supplement Report FDA Received Date: 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/24/2020
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: WA90002A SERIAL# (B)(6).
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 57 KG