MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. HF-RESECTION ELECTRODE; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number WA22306D

Device Problem Material Disintegration (1177)

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

Event Date 11/30/2022

Event Type  malfunction  

Event Description

A user facility reported to olympus that 2 olympus, model wa22306d, hf-resection electrodes, "disintegrated," as reported by the end user, during a transurethral resection of bladder tumor procedure.The intended procedure was completed using another device of the same model and lot number.The end user confirmed that nothing unusual was noted in relation to the case and the end user characterized the cautery settings as "typical." as reported to olympus, nothing fell into the patient and no patient serious injury occurred.This is report #1 of 2 due to multiple device failures reported.Reference report patient identifier (b)(6) for additional report.

Manufacturer Narrative

The investigation is ongoing and the definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation and device evaluation.The device was returned to olympus and evaluated.A visual inspection on the received condition of the device noted that the device was not returned in its original packaging.The distal end was observed under a microscope and confirmed that the loop was disintegrated.There is a portion missing from the loop and the missing portion was not returned for evaluation.The blue and yellow insulation on the forks is charred at the tips and slightly melted.The shaft and proximal end have no signs of excessive bends or deformities.Functional tests were unable to be performed because the loop is damaged.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 of the disintegrated electrode was due to wear and tear.Additionally, the loop at the distal end of the electrode can wear out during use and may break, burn or melt.The instructions for use identify the following warnings and cautions related to the phenomenon: "using incompatible equipment may lead to injury of the patient and/or the user as well as damage to the product." "improperly assembled equipment may cause infection, electrical, mechanical and thermal injury and/or unintended nerve stimulation." "bending the distal tip may damage the hf-resection electrode leading to sparkover between the hf-resection electrode and the telescope.There is a risk of electrical, mechanical and thermal injury and/or unintended nerve stimulation." "some electrosurgical generators have a so-called ¿spray coagulation¿ feature.Using the ¿spray coagulation¿ feature in combination with the equipment mentioned in this document may cause sparkover leading to electrical injury, thermal injury and/or unintended nerve stimulation.The ¿spray coagulation¿ feature must not be used." olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16063025
• MDR Text Key: 308492278
• Report Number: 9610595-2022-06208
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K100275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA22306D
• Device Catalogue Number: WA22306D
• Device Lot Number: 1000081970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2021
• 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