MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE; ROLLER ELECTRODE

Model Number	A22255C
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	02/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
It was reported the tip of the high frequency resection electrode broke while inside the patient during a hysteroscopy/dilation and curettage (d&c) procedure.The broken portion was retrieved.The procedure was completed with the same device.The device was discarded.There was no reported patient impact.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.Since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.However, the probable cause of the malfunction was due to wear and tear / the loop at the distal end of the electrode wears out during use and can break, burn or melt.The lot/serial number for the affected device could not be obtained.Therefore, a dhr review could not be performed.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being supplemented to provide a correction to the fields (h6) and to provide a correction with information inadvertently left out (g2 and h6).Correction to the previous h6 as 3331.And 10 were incorrectly selected.

• Brand Name: HF-RESECTION ELECTRODE
• Common Device Name: ROLLER ELECTRODE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18935494
• Report Number: 9610773-2024-00777
• Device Sequence Number: 6971727
• Product Code: GCP
• UDI-Device Identifier: 14042761036839
• UDI-Public: 14042761036839
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K954488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/05/2024

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: A22255C
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/11/2024; 08/05/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 06/12/2024; 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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