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

Model Number	WB990311
Health Effect - Clinical Codes	Necrosis (1971); Pain (1994)
Date of Event	11/12/2021
Type of Reportable Event	Serious Injury
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".

• 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
• MDR Report Key: 12972319
• Report Number: 2951238-2021-00447
• Device Sequence Number: 4647126
• Product Code: GEI
• UDI-Device Identifier: 14042761083536
• UDI-Public: 14042761083536
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/09/2021
• Report Date (Section F): 11/15/2021

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?: Yes
• Distributor Facility Aware Date: 11/15/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/15/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: WA90002A SERIAL# (B)(4).
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 57 KG