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 09/13/2023

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to an olympus repair center for evaluation and the customer¿s reported issue was confirmed.The device evaluation found e433 errors in the error log and that it was due to a defective generator board.It was also found that the relay board had worn contacts.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided.

Event Description

The customer reported that generator has a bistoury alarm error and restarts constantly.The issue was found in preparation for use for an unspecified procedure.There were no reports of harm.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's 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 root cause of the display of error code could not be determined as multiple possibilities existed.Possible causes for the error message e433 to occur are: 1.Malfunction of the esg-400 due to interspersed electromagnetic interference fields (temporary error).2.The user presses the footswitch during device startup (temporary error caused by user action).3.Defective foot switch due to a short circuit in the plug (temporary error 4.Defective footswitch due to defective reed contact (temporary error).5.Defective cable connection between board and generator board (temporary or permanent error).6.Defective cable connection for the output signal between the generator board and the relay board (temporary or permanent error).7.Defective transformer on the generator board (permanent error).8.Defective current transformer on the generator board (permanent error).9.Defective impedance converter on the generator board (permanent error).10.Defective peak value rectifier on the generator board (permanent error).11.Missing control for the output stage of the generator board (permanent error).12.Output voltage too low due to poorly switching output stage on the generator board (permanent error).13.No or too low supply voltage from the board (permanent error).14.Defective board due to short circuit of the transistors (permanent error).In such cases, popping noises or flashes can sometimes be observed or noticed by the user.15.Defective motherboard due to short circuit of resistor (permanent error).16.Defective motherboard (permanent error).17.Defective diodes on the relay board (permanent error).Olympus will continue to monitor field performance for this device.

• Brand Name: HF UNIT "ESG-400"
• Type of Device: ELECTROSURGICAL GENERATOR ESG-400
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18062249
• MDR Text Key: 327258335
• Report Number: 9610773-2023-03160
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042761076838
• UDI-Public: 04042761076838
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K203682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2023
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2017
• 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