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 Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a therapeutic hysteroscopic uterine lesion resection with diagnostic curettage, the distal end of the hf resection electrode fractured and dropped into the uterine cavity.It was immediately located and the fallen remnant was retrieved with a foreign body forceps.The reported event resulted in a procedural prolongation of less than 30 minutes.There were no reports of patient harm.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.

• 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: 50952319
• Report Number: 3007960282-2026-00145
• Device Sequence Number: 10446450
• 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): 09/30/2026

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: 1000165725
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Female