MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12-30, ESG TURIS

Model Number WA22706S

Device Problem Material Disintegration (1177)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2020

Event Type  malfunction  

Manufacturer Narrative

The referenced electrode was not returned for evaluation.Therefore, the root cause of the reported event cannot be determined.However, the investigation is ongoing.If additional information becomes available or if the device is returned at a later date, this report will be supplemented accordingly.

Event Description

The technical assistance center was informed that during a procedure, the customer was experiencing the loops at the distal end of two high frequency-resection electrodes "plasmaloop", were burning in half.No fragments fell into the patient.No patient injury was reported.The procedure was completed with a similar device.The customer noted that the doctors would need to pause during a procedure to wait for bubbles to go away so they can better visualize the area.This report is for 2 of 2 devices.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the legal manufacturer.The customer further reported that no device fragments fell into the patient and the device has been discarded.No additional information was reported the legal manufacturer performed the device history records for this device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The investigation was completed and the legal manufacturer determined that there is no manufacturing, material or processing related cause for this failure mode.The bubbles described are gases that become visible in the conductive irrigation fluid (saline) and are produced by electrolysis during transurethral resection in saline and these are normal.The poor visibility of the surgical area is directly related to inadequate flow or the use of an inadequate flow rate, which could lead to delays in the operation and may also increase the temperature of the irrigation fluid.In addition, inadequate flow facilitates the accumulation of flammable gases, which may result in exogenous burns or other injuries if these gases are ignited by an activated electrode.It is therefore essential to extract the gases from the body in a controlled manner.The likely cause for the described issues can be attributed to wear and tear as well as wrong handling.It is recommended the user afresh for appropriate handling with the instrument by carefully following the instructions in ifu and to check the fluid management for an adequate flow of the flushing fluid.Olympus will continue to monitor complaints for this device.

• Brand Name: HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12-30, ESG TURIS
• Type of Device: HF-RESECTION ELECTRODE "PLASMALOOP"
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 10822908
• MDR Text Key: 224686573
• Report Number: 9610773-2020-00263
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761085356
• UDI-Public: 14042761085356
• Combination Product (y/n): N
• PMA/PMN Number: K171965
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA22706S
• Device Catalogue Number: WA22706S
• Device Lot Number: 1000056790
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1