MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH CELONLAB ENT 100-120 V~ (KIT)

Model Number	WB991007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Numbness (2415)
Date of Event	06/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to the service center for evaluation as the user facility discarded the device after the procedure.An investigation to obtain more detailed information regarding the reported events is ongoing.
Event or Problem Description
The service center was informed that a few days post a therapeutic turbinate reduction, the patient reported experiencing a numb feeling in their mouth.According to the user facility, 30 days after the procedure the patient continues to experience the numbness in the same area.It is unknown if the patient was treated.
Additional Manufacturer Narrative
The probe used in the procedure was discarded not the celonlab ent 100-120 v~ (kit).
Additional Manufacturer Narrative
This supplemental report is being submitted to report the device evaluation results and additional information.The celonlab electrosurgical generator was returned to the service center for evaluation.A visual inspection was performed on the received device and found the rear identification label was slightly peeling off.The celonlab electrosurgical generator was then tested with a lab wb990210 celonprobreath probe and footswitch.The output power was observed at the distal tip upon activation.A power output test was performed and all output powers measured within standard specifications.Additionally, the wb991007 tested and passed the electrical patient safety leakage test.Based on the evaluation, the unit tested and passed all functional tests.The patient electrical safety leakage and all power outputs measured within safe standard specifications.The wb991007 celonlab electrosurgical generator tested to be working and fully functional.

• Brand Name: CELONLAB ENT 100-120 V~ (KIT)
• Common Device Name: CELONLAB ENT 100-120 V
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 8872097
• Report Number: 9610773-2019-00106
• Device Sequence Number: 11451409
• Product Code: GEI
• UDI-Device Identifier: 04042768910074
• UDI-Public: 04042768910074
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K032838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2019

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: WB991007
• Device Catalogue Number: WB991007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/29/2019
• Supplement Date Received by Manufacturer: 08/08/2019; 08/28/2019
• Initial Report FDA Received Date: 08/07/2019
• Supplement Report FDA Received Date: 08/08/2019; 09/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other