MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH 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 10/23/2023

Event Type  malfunction  

Event Description

The customer reported that while reprocessing his olympus hf generator unit in preparation for a transurethral prostate resection procedure an e433 code was present.There was no patient involvement during this event.

Manufacturer Narrative

The device has not been returned for evaluation.If additional information becomes available prior to the conclusion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

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 device in question was not sent in for the purpose of an investigation.For this reason, no conclusive test report was available.However, a meaningful photo depicting the reported error message e433 was attached to the complaint.It was noted that the error message e433 occurs when the effective value of the output signal falls below the specified limit, which normally indicates a low-impedance diode chain.In general, in the case of permanent error patterns, it can be assumed that only one component is faulty.Multiple failures are rare.The possible causes for the occurrence of error message e433 were given as follows: 1) malfunction of the esg-400 due to interspersed electromagnetic interference fields (temporary error).2) the user operates the footswitch while the generator is booting (temporary error caused by the user).3) defective foot switch (temporary error).It should be mentioned that this issue was addressed under capa 147p-017 which was implemented on 30 march 2015.4) defective foot switch (temporary error, defective reed contact).5) defective cable connection between the hvps board and generator board (temporary or permanent error).6) defective cable connection for the output signal between the generator board and relay board (temporary or permanent error).7) defective current transformer on the generator board (permanent error).8) defective impedance transformer on the generator board (permanent error).9) defective peak rectifier on the generator board (permanent error).10) insufficient output voltage due to poorly switching hf output stage on the generator board (permanent error).11) no or insufficient supply voltage from the hvps board (permanent error).12) defective motherboard (ntc1, permanent error).13) defective motherboard (adc, permanent error).14) defective tvs diodes on the relay board (permanent error).15) defective transformer tr1 on the generator board (permanent error).16) defective hvps board due to short circuit of the mos transistors (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: 18120524
• MDR Text Key: 329226096
• Report Number: 9610773-2023-03262
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042761076838
• UDI-Public: 04042761076838
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2021
• 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