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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12°
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OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12° Back to Search Results
Model Number WA22302D
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/11/2024
Event Type  malfunction  
Manufacturer Narrative
The device was returned and the evaluation found that the cutting ring was deformed to one side.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported, that the resection electrode had the distal end deformed.The issue was found during preparation for use for a therapeutic electroresection surgery that was completed with a similar device.There were no reports of patient harm.
 
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Brand Name
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12°
Type of Device
HF-RESECTION ELECTRODE
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 Key18964530
MDR Text Key338774789
Report Number9610773-2024-00832
Device Sequence Number1
Product Code FAS
UDI-Device Identifier14042761051665
UDI-Public14042761051665
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K120418
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 03/22/2024
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 NumberWA22302D
Device Lot Number1000122979
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/14/2024
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/11/2024
Initial Date FDA Received03/22/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/03/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
WA22367A
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