MAUDE Adverse Event Report: OLYMPUS MEDICAL PRODUCTS CZECH, SPOL. S R.O. HF-RESECTION ELECTRODE, ROLLER, 24-28 FR., 12° AND 30°

Model Number	WA22351C
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	12/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1-facility name: (b)(6) hospital.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 that during a transcervical resection (tcr) procedure, the roller of the subject device came off and fell into the uterus.The broken part was successfully retrieved.The procedure was then completed with a similar device.There were no further reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information and the results of the legal manufacturer's final investigation.The device was returned to olympus for inspection and the reported failure was confirmed.Visual inspection confirmed that the electrodes and arms of the product were deformed and that the electrodes were broken.Based on the results of the investigation, this event is caused by a component failure of the electrode.However, the definitive root cause of the reported issue could not be determined.The cause of the electrode/arm deformation and electrode rupture found during visual inspection cannot be determined, but it is possible that the deformation may have been caused by an external overload.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
Additional information was received from the customer that the roller was discharged from the body and was collected at the same time.There were no further diagnostic imaging performed.There were no further reports of patient harm.

• Brand Name: HF-RESECTION ELECTRODE, ROLLER, 24-28 FR., 12° AND 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: 21175302
• Report Number: 3007960282-2025-00008
• Device Sequence Number: 4300772
• Product Code: FAS
• UDI-Device Identifier: 14042761051719
• UDI-Public: 14042761051719
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100275 / K
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: WA22351C
• Device Lot Number: 1000134480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2024
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown