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

Model Number WB91051W

Device Problem Loss of Power (1475)

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

Event Date 09/27/2022

Event Type  malfunction  

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

The customer reporting during a transurethral resection of the prostate (turp), while using a bipolar device to resect on cautery and cut, it stopped working.The patient was bleeding when the malfunction happened.The staff turned the subject device off and on and it kept cycling with error code e433 "auto-restart.Contact oly." when the biotechnician got to the room, the device would not turn on.Per the technical guide, the error code is associated with an "internal hardware error" and the facility was advised to return the device to olympus for service.No additional information available.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the device evaluation.The device was returned to olympus for inspection, and it was confirmed that the reported issue (e433) was due to a faulty generator board.Additional non-reportable defects noted during the evaluation are as follows: minor scratches on the housing covers minor dents (deformed) top cover in the back.Minor scratches on the screen old software v11-a can be upgraded to v12-a.This supplemental report also includes information added to d9 and h3.

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.It has been over 3 years since the subject device was manufactured.Based on the results of the investigation, the likely causes for the occurrence of the reported error message (e433) are 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).Furthermore, if the error message e433 occurs only sporadically (temporarily), then no further action is necessary.In general, in the case of permanent error patterns, it can be assumed that only one component is faulty.This supplemental report includes a correction to e1 from initial medwatch.Also, information added to e2, e3 and g2.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, germany 22045 ; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 15672777
• MDR Text Key: 307102948
• Report Number: 9610773-2022-00504
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042761076838
• UDI-Public: 04042761076838
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 12/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2019
• 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
• Treatment: UNKNOWN BIPOLAR ACCESSORY