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

Model Number	WB991007
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	Shock (2072)
Date of Event	09/16/2020
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 1 or 2 reports and this is related to patient identifier number (b)(6).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer¿s investigation.Since the product was not returned to legal manufacturer, this investigation is based solely on the information provided by the customer.The product was sold on: 23.07.2013.According to the event description, there was an output malfunction of the affected celonlab and the patient felt an electric shock.During the investigation of the s-bc, no malfunction could be identified.Consequently, the device is evaluated to be in standard.Furthermore, the s-bc found scratches on the housing of the device.These are signs of wear and tear during use.As long as the function of the device is not affected by this finding, such visual damage can be evaluated to be not critical.Therefore, oste will not investigate this finding in the following.The cause for the reported cannot be definitely determined.The affected device is evaluated to be in standard.Our investigator assumes that the reported electric shocks were possibly be caused due to improper handling by the customer.It is possible that the patient was not correctly positioned.The patient, as well as all users that may be in touch with the patient, may not be grounded.Since the device is evaluated to be in standard, it is very unlikely that an increased risk associated with the reported issue is posed.A manufacturing and quality control review was performed for the affected lot number without showing any non-conformities or deviations regarding the described issue.There is no capa associated with this product with respect to the described issue.There are no countermeasures necessary, because the device is evaluated to be in standard.Oste will monitor the occurrence rate in the context of our quality management system.If necessary.There are no containment actions necessary, because the device is evaluated to be in standard.

• Brand Name: CELONLAB ENT 100-120 V~ (KIT)
• Common Device Name: ELECTROSURGICAL DEVICE AND ACCESSORIES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 10849020
• Report Number: 9610773-2020-00267
• Device Sequence Number: 10990427
• 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): 01/28/2021

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: 10/05/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 01/28/2021
• 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 (5PCS/BOX)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Weight: 91