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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH CELONLAB ENT 100-120 V~ (KIT); ELECTROSURGICAL DEVICE AND ACCESSORIES
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OLYMPUS WINTER & IBE GMBH CELONLAB ENT 100-120 V~ (KIT); ELECTROSURGICAL DEVICE AND ACCESSORIES Back to Search Results
Model Number WB991007
Health Effect - Clinical Code Electric Shock (2554)
Date of Event 09/21/2020
Type of Reportable Event Serious Injury
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).
 
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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 Key10864822
Report Number2951238-2020-00517
Device Sequence Number17225625
Product Code GEI
UDI-Device Identifier04042768910074
UDI-Public04042768910074
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 11/18/2020
Report Date (Section F) 11/05/2020
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 NumberWB991007
Device Catalogue NumberWB991007
Device Lot Number13175W500010
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/05/2020
Date Report to Manufacturer11/05/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date11/18/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
WB990210 (5PC/BOX)
Outcome Attributed to Adverse Event Other;
Patient Age79 YR
Patient Weight73
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