MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTIONELECTRODE"PLASMALOOP¿MEDIUM,30°",LOOP,24FR,STANDARD,12°-30°,FORTCRIS; ELECTRODES

Model Number	WA47506S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device was returned to the olympus repair center for evaluation and the customer¿s reported problem was confirmed, the loop wire at the distal end of the electrode was broken and in a molten spherical state on one end of the broken loop wire.No other defects were observed.The review of the device history records for the affected lot or serial number without showing any non-conformities or deviations regarding the described issue.The device was manufactured according to valid instructions and met all specifications.The investigation is still in progress; however, if additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
The customer reported, during the trans cervical resection in saline procedure the loop wire was cut off when output was performed twice using the high frequency resection electrode.The procedure was completed with another electrode from the same lot.The electrosurgical generator setting value was at 120watts.After replacing the electrode, 100watts setting was used.No death or injury was reported to olympus.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation (h6/h10).Based on the results of the investigation, the root cause of the reported event was usage-related wear and tear.The loop wire at the distal end of the hf-resection electrode wears out during use and may break, burn or melt.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTIONELECTRODE"PLASMALOOP¿MEDIUM,30°",LOOP,24FR,STANDARD,12°-30°,FORTCRIS
• Common Device Name: ELECTRODES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16678148
• Report Number: 9610773-2023-00962
• Device Sequence Number: 5347756
• Product Code: JOS
• UDI-Device Identifier: 14042761085042
• UDI-Public: 14042761085042
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2023

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: WA47506S
• Device Catalogue Number: WA47506S
• Device Lot Number: 1100391715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2023
• Supplement Date Received by Manufacturer: 06/19/2023
• Initial Report FDA Received Date: 04/04/2023
• Supplement Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2022
• 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: OLYMPUS MODEL: ESG-400.
• Patient Sex: Female