MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF UNIT "ESG-400"; ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES

Model Number WB91051W

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Patient Involvement (2645)

Event Date 11/30/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.The evaluation confirmed the user's report, which was attributed to a faulty generator board.In addition, there were minor scratches on top cover, and minor scratches and dings on the front panel of the device.The device was serviced, and returned to the user facility.

Event Description

It was reported that the device displayed an error message "e433" on the generator during system start up.No patient involvement, and no further information provided.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the legal manufacturer and to update the following sections: b5, d8, e2, g3, g6, h2, h4, h6 and h10.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 by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.The e433 error is activated by the device's safety system, which triggers a restart of the device.If the error cause persists, an unlimited number of periodic restarts can be triggered.In this case, error e433 was most likely caused by a defective generator board.A deeper investigation of generator boards with error e433 found a destroyed transformer to be the cause.An improved generator board was introduced into production in mid-july 2020.As stated on the instructions for use and as a preventive measure: according to the ifu, a suitable replacement device must be provided during an application.Olympus will continue to monitor complaints for this device.

Event Description

During a an unspecified therapeutic procedure, the high frequency electro-surgical generator unit had an error, e433.No patient injury or harm was reported.No further information was provided.

• Brand Name: HF UNIT "ESG-400"
• Type of Device: ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 11089582
• MDR Text Key: 227268634
• Report Number: 9610773-2020-00304
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042761076838
• UDI-Public: 04042761076838
• Combination Product (y/n): N
• PMA/PMN Number: K141225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WB91051W
• Device Catalogue Number: WB91051W
• Device Lot Number: B002594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1