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	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2026
Type of Reportable Event	Malfunction

• 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 ; +1(508)207-7661
• MDR Report Key: 50118533
• Report Number: 3007960282-2026-00138
• Device Sequence Number: 18672187
• Product Code: FAS
• UDI-Device Identifier: 14042761051665
• UDI-Public: 14042761051665
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K120418
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Type of Report: Initial
• Report Date (Section B): 08/03/2026

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: 1000142886
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/17/2026
• Initial Report FDA Received Date: 08/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/05/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Female