MAUDE Adverse Event Report: OLYMPUS MEDICAL PRODUCTS CZECH, SPOL. S R.O. HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12°

Model Number	WA22302D
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.Date of event is unknown.Additional information will be provided if available.
Event or Problem Description
The customer reported that the electrode was severely bent and the distal end was deviated from the shaft axis during an unspecified procedure involving an olympus hf-resection electrode.There was no patient injury reported.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12°
• 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 01581 ; 5082077661
• MDR Report Key: 25597160
• Report Number: 3007960282-2026-00127
• Device Sequence Number: 17555738
• Product Code: FAS
• UDI-Device Identifier: 14042761051665
• UDI-Public: 14042761051665
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: K100275 / K
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2026

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: WA22302D
• Device Lot Number: 08XW
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/05/2026
• Supplement Date Received by Manufacturer: 06/24/2026
• Initial Report FDA Received Date: 06/23/2026
• Supplement Report FDA Received Date: 07/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2008
• Is the Device Labeled for Single Use? (Y/N): No
• 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