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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF UNIT "ESG-400"; HIGH FREQUENCY ELECTROSURGICAL UNIT
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OLYMPUS WINTER & IBE GMBH HF UNIT "ESG-400"; HIGH FREQUENCY ELECTROSURGICAL UNIT Back to Search Results
Model Number WB91051C
Device Problem Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/03/2024
Event Type  malfunction  
Event Description
It was reported, that the electrosurgical generator had an e433 error.There were no reports of patient harm.
 
Manufacturer Narrative
The device was returned and the evaluation found that the high voltage power supply board was faulty causing an e433 error, the generator board was faulty, and the touchscreen had scratches.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
HF UNIT "ESG-400"
Type of Device
HIGH FREQUENCY ELECTROSURGICAL UNIT
Manufacturer (Section D)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg, hamburg 22045
GM  22045
Manufacturer (Section G)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg, hamburg 22045
GM   22045
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key18918193
MDR Text Key337854893
Report Number9610773-2024-00740
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K203682
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 03/15/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2024
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 Manufacturer03/08/2024
Was the Report Sent to FDA? No
Date Manufacturer Received03/03/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/04/2021
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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