MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OLYMPUS ESG-100, 220...240 V~,

Model Number WB991036

Device Problem Output Problem (3005)

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

Event Type  malfunction  

Manufacturer Narrative

To date, the device has not been returned to olympus for evaluation.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus that the olympus esg-100, 220.240 v had an error message showing.There were no reports of patient harm.The device was returned for evaluation and during the evaluation the following reportable malfunction was found: clarified the error as e317.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

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 root cause of the event was unable to be identified.The event likely occurred due to a faulty control board.Olympus will continue to monitor field performance for this device.

• Brand Name: OLYMPUS ESG-100, 220...240 V~,
• Type of Device: OLYMPUS ESG-100
• 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: 18304457
• MDR Text Key: 330559536
• Report Number: 9610773-2023-03590
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04042768910364
• UDI-Public: 04042768910364
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K073207
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2024

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: WB991036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/12/2023
• Initial Date FDA Received: 12/11/2023
• Supplement Dates Manufacturer Received: 01/12/2024
• Supplement Dates FDA Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2014
• 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