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

Model Number WB991046

Device Problem Communication or Transmission Problem (2896)

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

Event Date 09/01/2023

Event Type  malfunction  

Event Description

The customer reported that his olympus esg generator was displaying multiple error codes during procedure preparation.According to the initial reporter both e327 and e234 error codes were present.The customer noted that unplugging and plugging the unit back in did not resolve the issue.The intended procedure was not performed.

Manufacturer Narrative

The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, the user¿s report was confirmed.A defective printed circuit board was discovered and caused the reported failure mode.If additional information becomes available following the device evaluation, a supplemental report will be filed.

Manufacturer Narrative

This report is being supplemented to provide additional information including further information provided by customer the legal manufacturer's final investigation.(b3) date of event was added.According to the customer, the event occurred on (b)(6) 2023 during a therapeutic polypectomy.A pre-use inspection was performed as usual, and there were no abnormalities.After about 10 minutes, the error suddenly occurred, and there was no improvement even after restarting.Since the device could not be used, only observation and diagnosis could be performed.There was no report of patient harm.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.Based on the results of the investigation, the evaluation results indicated a communication board failure was the cause of the e234 and e327 errors.However, the legal manufacturer investigation determined that the communication board is not part of the circuitry that generates e234 or e327 error codes.Therefore, root cause could not be definitively determined.The error message 234 indicates a communication error between the generator board, and the control board.Data transmission is carried out via optical communication.If the micro-controller does not receive a response, a time-out occurs and error message 234 is generated to alert the user of the condition.The involved circuits are contained in the generator board, the control board, and the light guide cable.The error message e327 is generated when the voltage measurement on the control board is too low.The involved circuits are contained in the control board and the relay board.The error can result from a use issue where the electrode contact placement is poor, a faulty electrode or if calibration is needed.Olympus will continue to monitor field performance for this device.

• Brand Name: OLYMPUS ESG-100, 100...120 V~,
• Type of Device: 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: 17824980
• MDR Text Key: 324358788
• Report Number: 9610773-2023-02724
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042768910463
• UDI-Public: 04042768910463
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K073207
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

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 Operator: Health Professional
• Device Model Number: WB991046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/08/2023
• Initial Date FDA Received: 09/27/2023
• Supplement Dates Manufacturer Received: 02/14/2024
• Supplement Dates FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2021
• 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