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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE
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OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE Back to Search Results
Model Number A22201C
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code Foreign Body In Patient (2687)
Date of Event 08/14/2023
Type of Reportable Event Serious Injury
Event or Problem Description
The customer reported to olympus that part of the hf-resection electrode broke off inside the patient and the doctor was unable to find it, but it showed up on the x-ray in the patient.Additional procedural details were requested but not provided.
 
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Brand Name
HF-RESECTION ELECTRODE
Common Device Name
ELECTRODE
Manufacturer (Section D)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg, hamburg 22045
GM  22045
MDR Report Key17737923
Report Number2429304-2023-00293
Device Sequence Number5472615
Product Code GCP
UDI-Device Identifier14042761036648
UDI-Public14042761036648
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/13/2023
Report Date (Section F) 08/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberA22201C
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date08/15/2023
Event Location Hospital
Date Report to Manufacturer08/15/2023
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date09/13/2023
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient SexUnknown
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