MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF UNIT "ESG-400"; HIGH FREQUENCY ELECTRO-SURGICAL GENERATOR UNIT

Model Number WB91051W

Device Problems Electrical /Electronic Property Problem (1198); Defective Component (2292)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4): investigation still in progress oste investigation results: since the product for this info complaint was not returned to oste, our investigation is based solely on the information provided by the customer.The product was sold on: (b)(6) 2018.

Event Description

Olympus (obl) was informed that the asset high frequency electro-surgical generator unit was returned to the service center for evaluation.There was no defect or malfunction associated with the device.However, upon inspecting and testing, the generator displayed an e433 error code which was attributed to a defective generator board.No death, injury or harm was reported to olympus.

Manufacturer Narrative

Correction to g3 of the initial medwatch.The aware date should be 11-jan-2022.Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 cause of the e433 could be a result of the following: the user activates the foot switch while the generator is booting, faulty foot switch, defective cable connection between hvps board and generator board, defective hvps board, defective generator board, or defective motherboard.The generator boards with error e433 found a destroyed transformer tr1 to be the cause.The subject device within this report was manufactured prior to a design change that was implemented to prevent reoccurrence.Olympus will continue to monitor field performance for this device.

• Brand Name: HF UNIT "ESG-400"
• Type of Device: HIGH FREQUENCY ELECTRO-SURGICAL GENERATOR UNIT
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 14116330
• MDR Text Key: 298804591
• Report Number: 9610773-2022-00140
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042761076838
• UDI-Public: 04042761076838
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K203682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 01/11/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/19/2022
• Initial Date FDA Received: 04/14/2022
• Supplement Dates Manufacturer Received: 04/27/2022
• Supplement Dates FDA Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2018
• 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