MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMALOOP ¿ MEDIUM, 30°", 24 FR., STANDARD, 12°-30°

Model Number	WA47506S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported, the electrode's tip was crushed.The issue occurred during preparation for use.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The customer's allegation was confirmed.Three attempts were performed to obtain additional information, but no response was received from the customer.Based on the results of the investigation, it is likely that the following led to the malfunction: the product was deformed due to overload between the completion of manufacturing and the time of opening.It is not possible to determine whether there was an undetected quality defect or the deformation at the distal end of the electrode was caused when it was removed from the blister.A definitive root cause cannot be identified.A device history review revealed no issues that could have caused or contributed to the reported issue.Olympus will continue to monitor the field performance of this device.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: HF-RESECTION ELECTRODE "PLASMALOOP ¿ MEDIUM, 30°", 24 FR., STANDARD, 12°-30°
• Common Device Name: 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20014373
• Report Number: 9610773-2024-02006
• Device Sequence Number: 15268373
• Product Code: JOS
• UDI-Device Identifier: 14042761085042
• UDI-Public: 14042761085042
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2025

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
• Operator of Device: Health Professional
• Device Model Number: WA47506S
• Device Lot Number: 1000119827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2024
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown