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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH BERLIN FACILITY ELECTROSURGICAL GENERATOR "ESG-410"; WA91307C
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OLYMPUS WINTER & IBE GMBH BERLIN FACILITY ELECTROSURGICAL GENERATOR "ESG-410"; WA91307C Back to Search Results
Model Number WA91307C
Medical Device Problem Code Output Problem (3005)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 11/01/2024
Type of Reportable Event Serious Injury
Event or Problem Description
During sedation of an unknown therapeutic procedure there was a delay greater than 30 minutes due to the generator displaying an e0728 internal hardware failure error.There were no reports of patient harm.
 
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Brand Name
ELECTROSURGICAL GENERATOR "ESG-410"
Common Device Name
WA91307C
Manufacturer (Section D)
OLYMPUS WINTER & IBE GMBH BERLIN FACILITY
rheinstrasse 8
odakura, nishigo-mura,
teltow, brandenburg 14513
GM  14513
MDR Report Key20732901
Report Number2429304-2024-01003
Device Sequence Number8904797
Product Code GEI
UDI-Device Identifier04042761086349
UDI-Public04042761086349
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Importer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 11/20/2024
Report Date (Section F) 11/20/2024
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 NumberWA91307C
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date11/01/2024
Event Location Ambulatory Surgical Facility
Date Report to Manufacturer11/01/2024
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date11/20/2024
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device A
Patient Sequence Number1
Patient SexUnknown
Date Report Sent to FDA11/20/2024
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