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

Model Number	WB991007
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	Shock (2072)
Date of Event	09/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The electrosurgical unit (esu) was returned to olympus for evaluation.The evaluation did not duplicate the user¿s report as the device passed the safety check inspection.Based on the visual inspection of the esu interior and exterior found no anomaly.The esu was checked for functionality using a test metron electrosurgical analyzer and a footswitch.The generator passed the display function check, power output, valid resistance range, and high frequency leakage current.
Event or Problem Description
It was reported that the unit had no output and it was not firing.The unit was showing a signal that the probe was not in the correct place even when it was.In addition, the physician reported that the unit is shocking patients in addition to the probes not working when properly placed in the turbinate anatomy.The user facility further reported that there were actually two patients involved.Both of the patients had a nasal submucous turbinate reduction procedure.There was no reported permanent damage with both patients and no additional intervention provided to the patients.This report is 2 of 2 reports, and is related to (b)(4).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to correct information provided on the initial report.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It is unclear what caused the reported electric shocks.Though, it is likely caused by user error where the patient might not have been positioned correctly.The patient and all users who may have come in contact with the patient during the procedure must not have been grounded during the application.

• Brand Name: CELONLAB ENT 100-120 V~ (KIT)
• Common Device Name: ELECTROSURGIAL DEVICE AND ACCESSORIES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 10864721
• Report Number: 9610773-2020-00270
• Device Sequence Number: 19492038
• Product Code: GEI
• UDI-Device Identifier: 04042768910074
• UDI-Public: 04042768910074
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K032838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: WB991007
• Device Catalogue Number: WB991007
• Device Lot Number: 13175W500010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/05/2020
• Supplement Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 02/12/2021
• 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: WB990210 (5PC/BOX)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Weight: 73