MAUDE Adverse Event Report: OLYMPUS MEDICAL PRODUCTS CZECH, SPOL. S R.O. HF-RESECTION ELECTRODE "PLASMALOOP ¿ MEDIUM, 30°", 24 FR., STANDARD, 12°-30°

Model Number	WA47506S
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported both the left and right sides of the resection electrode loop came off.This issue occurred during a therapeutic polymerase chain reaction (pcr) procedure.There was no delay, and the procedure was completed with a similar device.There were no reports of patient harm.
Additional Manufacturer Narrative
Updated fields e4, h3, h4, h6.This supplemental report is being submitted to provide the results of the final investigation.The device was returned to olympus for inspection and the reported failure was confirmed.A root cause was identified to be component failure.Based on the results of the investigation, it is likely the following led to the malfunction: it is possible that the electrode loop break could have been caused by an external overload.The event can be detected/prevented by following the instructions for use which state: "chapter 5 preparation¿.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported both the left and right sides of the resection electrode loop came off.This issue occurred during a therapeutic polymerase chain reaction (pcr) procedure.There was no delay, and the procedure was completed with a similar device.There were no reports of patient harm.

• Brand Name: HF-RESECTION ELECTRODE "PLASMALOOP ¿ MEDIUM, 30°", 24 FR., STANDARD, 12°-30°
• Common Device Name: HF-RESECTION ELECTRODE
• Manufacturer (Section D): OLYMPUS MEDICAL PRODUCTS CZECH, SPOL. S R.O.; telickova 457/29; prerov 75124 ; EZ 75124
• Manufacturer (Section G): OLYMPUS MEDICAL PRODUCTS CZECH, SPOL. S R.O.; telickova 457/29; prerov 75124 ; EZ 75124
• Manufacturer Contact: todd brill ; 801 west park drive; westborough, MA 01582 ; 5082077662
• MDR Report Key: 21527220
• Report Number: 3007960282-2025-00030
• Device Sequence Number: 7735263
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2025

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2023
• 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