MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH WORKING ELEMENT, PASSIVE, FOR TURIS

Model Number WA22061B

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/22/2019

Event Type  malfunction  

Manufacturer Narrative

As part of our investigation, olympus followed up with the user facility to obtain additional information regarding the reported event.The user facility further reported that prior to sending the device in for service, the device was tested and had no further issues.No additional information was provided regarding the patient, procedure and the devices involved during the case.The device was returned to olympus but the evaluation is in progress.If additional information becomes available, this report will be supplemented accordingly.

Event Description

Olympus was informed that during procedure, the working element that was attached to the generator, esg-400, burned and there was smoke/burning smell noted.There was no patient or user injury reported.2 of 2 devices.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the dhr review the oem conducted a dhr review for the affected lot number which indicated no deviations or non-conformities during the manufacturing of the device.

Manufacturer Narrative

The device was returned to olympus for evaluation.The user facility returned a wa22061b working element for an evaluation.A visual inspection of the returned device was performed and noticed the smoke/burning smell.¿ based on the evaluation, rust and corrosion was noted on the shaft.Also, a water leak test was performed and it failed the water leak test.The cause is most likely due to a bad seal within the handle.As a preventive measure, the owner¿s manual contains warnings and cautions; before use.¿make sure that the product has been properly reprocessed, inspected, and tested.¿ inspecting the product.¿visually inspect the product.Make sure that it has: no corrosion, no dents, no scratches." ¿do not activate the electrode release button when operating the instrument.If hf current is activated, spark discharge may occur and the instrument may be damaged.

• Brand Name: WORKING ELEMENT, PASSIVE, FOR TURIS
• Type of Device: WORKING ELEMENT
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 8446351
• MDR Text Key: 139664400
• Report Number: 2951238-2019-00571
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• PMA/PMN Number: K030194
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA22061B
• Device Lot Number: 052W-0031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS: GENERATOR ESG-400, SN (B)(4)