MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 12°

Model Number	WA22503D
Medical Device Problem Code	Electrostatic Discharge (2149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, the olympus high frequency resection electrode was in use when the doctor saw an electric arc between two high frequency cable attachment pins from the resectoscope.The doctor was not affected and did not feel anything.The issue was found during a prostate operation.The equipment was changed and the procedure was completed successfully with the new set of devices.The procedure was extended for 20 minutes with the patient under anesthesia.There were no reports of patient injury or medical intervention associated with this event.Related patient identifiers are as follows: (b)(6) (wa22366a - working element, active, for resection in saline), (b)(6) (esg-400 - hf-unit), (b)(6) (wa00014a - hf-cable, bipolar).
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer's allegation was not confirmed.The device evaluation did not identify any malfunction of the high frequency resection electrode.A review of the device history record for the affected lot number found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, a definitive root cause could not be determined because the electrode was evaluated to meet the specification.Olympus will continue to monitor the field performance of this device.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 12°
• Common Device Name: HF-RESECTION 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 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18326894
• Report Number: 9610773-2023-03624
• Device Sequence Number: 15333680
• Product Code: FAS
• UDI-Device Identifier: 14042761068205
• UDI-Public: 14042761068205
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K120418
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/14/2023

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: WA22503D
• Device Lot Number: 1000112718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2023
• Initial Report FDA Received Date: 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HF-CABLE, BIPOLAR (208W-4101); HF-UNIT ESG-400 (B001235); WORKING ELEMENT FOR RESECTION IN SALINE (4YW-0030)
• Patient Sex: Unknown