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

Model Number WA22503D

Device Problem Electro-Static Discharge (2149)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/26/2023

Event Type  malfunction  

Event 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).

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°
• Type of Device: 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
• MDR Text Key: 330948697
• Report Number: 9610773-2023-03624
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761068205
• UDI-Public: 14042761068205
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K120418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 11/27/2023
• Initial Date FDA Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HF-CABLE, BIPOLAR (208W-4101); HF-UNIT ESG-400 (B001235); WORKING ELEMENT FOR RESECTION IN SALINE (4YW-0030)