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

Model Number WB91051W

Device Problem Defective Component (2292)

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

Event Type  malfunction  

Manufacturer Narrative

The device was evaluated, and the customer¿s allegation was confirmed.In addition to the e433 code (generator defective), there were no additional findings.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 root cause of the event was unable to be identified; however, the event most likely occurred due to a faulty generator board.Olympus will continue to monitor field performance for this device.(b)(6).

Event Description

It was reported to olympus that the hf unit "esg-400" had an error occur and unit switches itself off.The event was found during a procedure.There was no patient harm associated with the event.The device was evaluated, and it was found that there was an error code e433 (generator board defective).This mdr (medical device report) is being submitted to capture the reportable malfunction found during the device evaluation.

• Brand Name: HF UNIT "ESG-400"
• Type of Device: ELECTROSURGICAL GENERATOR ESG-400
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH BERLIN FACILITY; rheinstrasse 8; teltow, brandenburg 14513 ; GM 14513
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH BERLIN FACILITY; rheinstrasse 8; teltow, brandenburg 14513 ; GM 14513
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17736097
• MDR Text Key: 323287663
• Report Number: 3003724334-2023-00035
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042761076838
• UDI-Public: 04042761076838
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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
• Type of Report: Initial
• Report Date: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WB91051W
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2012
• 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