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

Model Number WB91051W

Device Problem Communication or Transmission Problem (2896)

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

Event Date 12/15/2023

Event Type  Injury  

Event Description

User facility reported during a diagnostic procedure, when hf unit "esg-400" was turned on there was an error message.The device then began to make a clicking sound.The procedure was completed using a manual technique resulting in a 30-45 minute delay.

Manufacturer Narrative

The device was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Additionally, to provide a correction to fields (d9, h3, and h4).The device was evaluated by olympus, and it was confirmed that e433 occurred and (hvps) high voltage power supple board was defective.Additionally, there were non-reportable (non-pae) defects noted.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, it is likely that the e422 error message occurred which led to a delay in the procedure because of one of the following reasons: 1.Disturbance of the esg-400 due to interspersed electromagnetic interference fields (temporary error).2.The user actuates the foot switch while the generator is booting (temporary error caused by user action).3.Defective foot switch due to short circuit in the plug (temporary error).This case was addressed by capa 147p-017, implemented on 30.03.2015.4.Defective foot switch due to defective reed contact (temporary error).5.A defective cable connection between the hvps board and the generator board (temporary or permanent error).6.A defective cable connection for the output signal between the generator board and the relay board (temporary or permanent error).7.A defective transformer tr1 on the generator board (permanent error).8.A defective current transformer on the generator board (permanent error).9.A defective impedance transformer on the generator board (permanent error).10.A defective peak rectifier on the generator board (permanent error).11.A missing drive signal for the output stage of the generator board (permanent error).12.The output voltage is too low due to bad switching of the hf output stage on the generator board (permanent error).13.The supply voltage from hvps board is missing or too low (permanent error).14.A defective (hvps) board due to a short circuit of the mos transistors (permanent error).In such cases, the user may sometimes observe popping noises or flashes.This could be caused by a defective transformer tr5 on the motherboard, which incorrectly switches the hvps from a mains voltage of 230v to 110-volt operation.15.A defective motherboard due to a short circuit of the ntc1 resistor (permanent error).16.A defective motherboard due to a defective adc (permanent error).17.Defective tvs diodes on the relay board (permanent error).However, the root cause of the reported event could not be identified.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 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: 18492133
• MDR Text Key: 332650586
• Report Number: 3003724334-2024-00001
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042761076838
• UDI-Public: 04042761076838
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K203682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WB91051W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other