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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, CUTTING & COAGULATION & ACCESSORIES
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OLYMPUS WINTER & IBE GMBH HF UNIT "ESG-400"; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Model Number WB91051W
Device Problem Intermittent Energy Output (4025)
Patient Problems Laceration(s) (1946); Unspecified Tissue Injury (4559)
Event Date 01/17/2022
Event Type  Injury  
Event Description
The customer reported during a procedure, the device was cauterizing distally but not proximally and the patient had an unspecified injury.The physician had to put a clip or staple to address the injury and the patient will require a separate follow up procedure due to the event.The subject device was being used with maj-860.
 
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Brand Name
HF UNIT "ESG-400"
Type of Device
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg, hamburg 22045
GM  22045
MDR Report Key13536448
MDR Text Key285685119
Report Number2951238-2022-00319
Device Sequence Number1
Product Code GEI
UDI-Device Identifier04042761076838
UDI-Public04042761076838
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 01/17/2022,02/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberWB91051W
Device Catalogue NumberWB91051W
Device Lot Number15345W140017
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/27/2022
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date01/17/2022
Event Location Hospital
Date Report to Manufacturer01/17/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
MAJ-860, UNKNOWN LOT
Patient Outcome(s) Other;
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