MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OLYMPUS ESG-100, 100...120 V~,; ELECTROSURGICAL SYSTEM GENERATOR

Model Number WB991046

Device Problems Device Emits Odor (1425); No Device Output (1435)

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

Event Date 04/07/2023

Event Type  Injury  

Manufacturer Narrative

The suspect device has been returned to olympus for evaluation.The power switch was turned on and the device would not boot.The device output could not be checked because the device would not start.There was no burning smell observed nor were there any abnormalities with the device's appearance.The failure location could not be identified.The moment the power switch was pressed, the display lit up instantaneously, and noise was generated from the device while it was energized.This may indicate that the device's circuit protection function is causing a faulty power input.The cause of the malfunction of the circuit protection function is that the circuit protection function failed due to unintentional short-circuit during output during use inspection, or other parts failed, but it was not identified.Additional information is being requested.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

An olympus representative reported to olympus on behalf of the customer that the electrosurgical unit exhibited no output and emitted a burning smell during an endoscopic mucosal resection.The procedure was carried out up to the local injection to the affected area and was then cancelled due to no output.The procedure was rescheduled to (b)(6).The device was inspected prior to use and there was no reaction when the plate was attached.There was reportedly no patient impact.

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, users may report the power output is too low or the surgical result is insufficient.There are a number of possibilities that can result in an inadequate surgical performance, and the majority of them can be traced back to insufficient power output into the tissue.Possible causes are: defective cable connection to the connected instrument; defective hand instrument; contamination of the hand instrument due to adhering tissue deposits; contact resistances at the contact points of the hand instrument; in case of a monopolar application an incorrectly attached neutral electrode and/or a defective supply line to the neutral electrode; incorrect setting of the power on the generator by the user; an insufficient adjustment of the generator; a defect in the generator.In addition, the electrical conditions in the tissue of the surgical area may also cause the problem.Based on the complaint information, the procedure was cancelled due to "no power-up" and "device burnt smell" which were likely caused by a hardware defect.However, olympus cannot determine a definitive cause based on the information available.Per the instructions for use, the customer is required to check the function of all devices used prior to a procedure and a suitable replacement device must be provided during an application.Olympus will continue to monitor field performance for this device.

• Brand Name: OLYMPUS ESG-100, 100...120 V~,
• Type of Device: ELECTROSURGICAL SYSTEM GENERATOR
• 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: 16892667
• MDR Text Key: 314804852
• Report Number: 9610773-2023-01252
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042768910463
• UDI-Public: 04042768910463
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WB991046
• Device Catalogue Number: WB991046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/11/2023
• Initial Date FDA Received: 05/08/2023
• Supplement Dates Manufacturer Received: 09/04/2023
• Supplement Dates FDA Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2021
• 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
• Patient Outcome(s): Other