MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, 45° NEEDLE, 24-28 FR., 12° AND 30°, STERILE, SINGLE USE; ELECTROSURGICAL ELECTRODE, BIPOLAR

Model Number WA22355C

Device Problem Arcing (2583)

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

Event Date 03/28/2023

Event Type  malfunction  

Manufacturer Narrative

The device has been returned but the device evaluation is not yet begun.As such, a definitive root cause of the reported complaint cannot be determined at this time.Supplemental report(s) will be filed as any relevant new information becomes available.

Event Description

As reported for this event by the customer, during a therapeutic urology procedure, when the high frequency resection electrode device was used with the generator, an electrical arc occurred.Second attempt with the device repeated the electrical arc.The physician then switched back to monopolar with a monopolar loop and glycocolle.The procedure was completed with some delay.There is no harm or adverse impact to the patient.This was the first device used on this patient.However, other devices from the box had been used in other procedures with no issue.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for inspection, and the customer's complaint was confirmed.The needle of the electrode was found bent to the side.The 45° angle as well as the electrical function were given.There are no signs of a short circuit.No error message of the generator was reported.Furthermore, we assume that the user reprocessed and repeatedly used this single-use electrode.The multiple use of single-use products is not permitted and represents an interference with the safety of the device.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause could not be determined.It is likely the bent needle which caused the reported event occurred due to the use of excessive force from improper handling and/or the repeated use of a single use product.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE, 45° NEEDLE, 24-28 FR., 12° AND 30°, STERILE, SINGLE USE
• Type of Device: ELECTROSURGICAL ELECTRODE, BIPOLAR
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 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: 16799571
• MDR Text Key: 313952489
• Report Number: 9610773-2023-01126
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761030615
• UDI-Public: 14042761030615
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 05/30/2023

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: WA22355C
• Device Catalogue Number: WA22355C
• Device Lot Number: 1000050538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/28/2023
• Initial Date FDA Received: 04/24/2023
• Supplement Dates Manufacturer Received: 05/11/2023
• Supplement Dates FDA Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2019
• 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: ESG-400