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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH BERLIN FACILITY HF UNIT "ESG-400"; HIGH FREQUENCY ELECTROSURGICAL UNIT
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OLYMPUS WINTER & IBE GMBH BERLIN FACILITY HF UNIT "ESG-400"; HIGH FREQUENCY ELECTROSURGICAL UNIT Back to Search Results
Model Number WB91051C
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/22/2024
Event Type  malfunction  
Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported the high-frequency electrosurgical unit displayed an error e433 (malfunction of the generator).There were no reports of patient harm.
 
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Brand Name
HF UNIT "ESG-400"
Type of Device
HIGH FREQUENCY ELECTROSURGICAL UNIT
Manufacturer (Section D)
OLYMPUS WINTER & IBE GMBH BERLIN FACILITY
rheinstrasse 8
teltow, brandenburg 14513
GM  14513
Manufacturer (Section G)
OLYMPUS WINTER & IBE GMBH BERLIN FACILITY
rheinstrasse 8
teltow, brandenburg 14513
GM   14513
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key19215658
MDR Text Key341895546
Report Number3003724334-2024-00093
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 04/30/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberWB91051C
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/23/2024
Was the Report Sent to FDA? No
Date Manufacturer Received04/22/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/30/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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