MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF UNIT "ESG-400"; ELECTROSURGICAL GENERATOR ESG-400

Model Number WB91051W

Device Problem Unexpected Shutdown (4019)

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

Event Date 08/04/2022

Event Type  malfunction  

Manufacturer Narrative

The suspect device was sent to an olympus service center for evaluation.Inspection and testing confirmed the error code e433 occurred.A review of the device history record found no deviations that could have caused or contributed to the error code.The device shipped according to specifications.Based on the results of the legal manufacturer's investigation, it is likely the error occurred due to a faulty generator board.Error e433 is triggered by the safety system of the device and results in a restart of the generator.Previous investigation of generator boards with error e433 found a transformer to be the cause.Beginning in july 2020, an improved generator board was introduced into production.However, a definitive root cause of the reported issue could not be identified.Olympus will continue to monitor field performance for this device.In addition, the top cover was slightly deformed and there were minor scratches on the housing due to handling.Per the legal manufacturer, these device defects have no potential to cause or contribute to death or serious injury if the malfunctions were to recur.

Event Description

The customer reported that, during preparation of the device, error code e433 occurred on the subject device.There was no harm or user injury reported due to the event.

• Brand Name: HF UNIT "ESG-400"
• Type of Device: ELECTROSURGICAL GENERATOR ESG-400
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, . 22045 ; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg, . 22045 ; GM 22045 ; 4066966295
• MDR Report Key: 15634499
• MDR Text Key: 307072520
• Report Number: 9610773-2022-00489
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042761076838
• UDI-Public: 04042761076838
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1