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 09/29/2021

Event Type  malfunction  

Manufacturer Narrative

The device is returned and an evaluation completed for it.The user¿s complaint was confirmed.Upon inspection and testing, the error 433 was observed.This is attributed to the faulty generator board card, which needed replacing.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.

Event Description

As reported by the customer, during a rtu procedure the 433 error message was observed for the device.The procedure was completed with the same device.There is no reported harm or adverse impact to the patient.

Manufacturer Narrative

There is more information on the device evaluation.This supplemental report is being submitted to provide this information.The defective had to be replaced according to the technical cause and current service manual.

Manufacturer Narrative

There is more information on the device evaluation.Additional information received from customer.This supplemental report is being submitted to provide this information.Please see the updates in sections: a2, a3, a5, b7, d8, d10, g3, g6, h2, h3, h4, h6, and h10.The procedure was a therapeutic transurethral resection of the prostate with plasma.The event occurred at the beginning of the procedure.The procedure was completed with other non-olympus device.There was a 20 minute delay in the procedure.The doctor in charge of the procedure removed the plasma equipment from the surgical field, replacing it with a monopolar equipment of another brand.The patient did not need to be given additional anesthesia.The device was not inspected before use by the doctor.The device history record review confirmed that device was manufactured according to valid instructions and met all specifications.There is no non-conformity associated with this device with respect to the described issue.The device was sold to the customer on november 25, 2019.Error e433 is triggered by the safety system of the esg-400 and results in a restart of the generator.If the cause of the error remains, there may be an unlimited number of periodic restarts.Any error messages that may appear are triggered by the safety system of the esg-400 and communicated visually and acoustically to the user.They are part of the device's own security concept.In particularly critical cases, further use of the device is prevented by the security system until the error has been corrected.In general, the customer is required to check the function of all devices used prior to a procedure.Additionally, according to the instructions for use, a suitable replacement device must be provided during an application.In february 2020, a deeper investigation of generator boards with error e433 found a destroyed transformer tr1 to be the cause.An improved generator board was introduced into production in mid-july 2020.Presently, an in-depth investigation of the high voltage power supply (hvps) boards with error message e433 is being carried out by research and development.

• 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 Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 12665652
• MDR Text Key: 277720680
• Report Number: 9610773-2021-00297
• 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: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: WB91051W
• Device Catalogue Number: WB91051W
• Device Lot Number: B006660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/29/2021
• Initial Date FDA Received: 10/20/2021
• Supplement Dates Manufacturer Received: 10/27/2021; 11/05/2021
• Supplement Dates FDA Received: 11/02/2021; 11/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2019
• 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: KARL STORZ IMAGE1 CAMERA HEAD.; KARL STORZ IMAGE1 LIGHT SOURCE.; KARL STORZ IMAGE1 MONITOR.
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic
• Patient Race: American Indian Or Alaskan Native, White