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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

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OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL Back to Search Results
Model Number WA22302D
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/30/2023
Event Type  malfunction  
Event Description
The customer reported to olympus, the user noticed damage/deformation to the loop at the distal end of the high-frequency electrode.The issue was found at the start of the therapeutic procedure, when the resectoscope was inserted into the patient.The procedure was completed using a similar device.There were no reports of patient harm.
 
Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.Entire model description in d1: hf-resection electrode,loop.24 fr., 0.2 wire, medium 12° sterile single use, 12 pcs., for turis.
 
Manufacturer Narrative
This supplemental report is to inform that upon further review, this is not a reportable malfunction.The initial medwatch reported the subject device had damage/deformation to the loop at the distal end of the high-frequency electrode; however; the damage was at the proximal end which is not a reportable malfunction.Per the legal manufacturer, this issue at the proximal end is not likely to cause or contribute to death or serious injury if the malfunction were to recur.
 
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Brand Name
HF-RESECTION ELECTRODE, LOOP
Type of Device
ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
Manufacturer (Section D)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg
hamburg, hamburg 22045
GM  22045
Manufacturer (Section G)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key16908484
MDR Text Key314980951
Report Number9610773-2023-01279
Device Sequence Number1
Product Code FAS
UDI-Device Identifier14042761051665
UDI-Public14042761051665
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K100275
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 11/09/2023
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 NumberWA22302D
Device Catalogue NumberWA22302D
Device Lot Number1000099486
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/20/2023
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/11/2023
Initial Date FDA Received05/10/2023
Supplement Dates Manufacturer Received11/09/2023
Supplement Dates FDA Received11/09/2023
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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