MAUDE Adverse Event Report: OLYMPUS MEDICAL PRODUCTS CZECH, SPOL. S R.O. HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12°

Model Number	A22201C
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	08/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the resection electrode broke inside the patient's uterus during an unknown therapeutic procedure.A search was conducted for the missing end, which was found inside the patient's uterus.There were no reports of patient harm.Further follow-up is conducted to obtain additional information and is currently pending.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.Updated fields- b5, d4 lot number and d4- expiration date, d8, d9, d10, g1, h2, h3, h4, h6, h11 correction: e1.The device was returned to olympus and the reported failure was confirmed.The fracture fragment was available for investigation.Additionally, device inspection found the loop was broken off in its entirety.Based on the results of investigation, the most probable cause of the issue was the cause not established, which indicates that the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.Olympus will continue to monitor field performance for this device.
Event or Problem Description
Additional information identified that the procedure was a operative hysteroscopy for polypectomy, myomectomy for endometrectomy.The device was retrieved using non-energy resection loop.No unplanned diagnostic imaging was used to locate the device or confirm that it was being removed.The procedure was delayed for 20 minutes while the patient was under general anesthesia.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.The investigation confirmed the customer failure and determined the following cause : the loop wire of the broken wire fragment does not show much wear in the active zone but does show signs of mechanical deformation at both ends where the wire broke.At the same time, the electrode¿s shaft is slightly bent.Additionally, a small part of the wire fragment on one far end of the cutting loop is discolored but the loop did not break at this location.The discolored area on the wire fragment could have been caused by contact with a metal object.The rough surfaces of the broken ends of the wire indicate that the wire fragment broke off due to an excessive amount of force applied to the wire.Updated field- b3 and g1.
Event or Problem Description
The customer provided the event date.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 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: 21971664
• Report Number: 3007960282-2025-00057
• Device Sequence Number: 18265811
• Product Code: GCP
• UDI-Device Identifier: 14042761036648
• UDI-Public: 14042761036648
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K954488
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/01/2025

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: A22201C
• Device Lot Number: 1000153566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/09/2025
• Supplement Date Received by Manufacturer: 07/16/2025; 10/22/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 07/23/2025; 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NON-ENERGY RESECTION LOOP.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female