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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF UNIT "ESG-400"; ELECTROSURGICAL GENERATOR ESG-400
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OLYMPUS WINTER & IBE GMBH HF UNIT "ESG-400"; ELECTROSURGICAL GENERATOR ESG-400 Back to Search Results
Model Number WB91051C
Device Problem Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/27/2023
Event Type  malfunction  
Event Description
The customer reported to olympus that the hf unit "esg-400" had an e006 error report.The issue was found during preparation for use.There were no reports of patient harm.
 
Manufacturer Narrative
The device was returned to olympus for evaluation, and the customer¿s allegation was not confirmed as no fault was found.The investigation is ongoing and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
 
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Brand Name
HF UNIT "ESG-400"
Type of Device
ELECTROSURGICAL GENERATOR ESG-400
Manufacturer (Section D)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg, hamburg 22045
GM  22045
Manufacturer (Section G)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg 22045
GM   22045
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key18314950
MDR Text Key330938127
Report Number9610773-2023-03605
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,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 12/12/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
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 Manufacturer12/03/2023
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/27/2023
Initial Date FDA Received12/12/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/09/2015
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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