MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH FOOT SWITCH, SINGLE, FOR, ESG-400; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	WB50403W
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, the esg-400 displayed error code e433 (internal software or hardware error) and automatically restarted.The foot switch, single, for, esg-400 was disconnected, and the error code was cleared.There were no reports of patient harm.
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Corrected fields: h6 (type of investigation code: 4111 - communication/interviews must be removed).Additional information added to fields d4 (lot number must be removed) and h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 11 years since the subject device was manufactured.The device was not returned to olympus for inspection, and the customer's allegation was not confirmed.Based on the results of the investigation, in general, the displaying of e433 can have a considerable number of causes, including a defective foot switch.If e433 is displayed sporadically (temporarily), no further action needs to be taken.If it is displayed more often, it is recommended from experience to test the generator board, the hvps-board, the motherboard and relay board in another esg-400 and replace them, if necessary.Only rarely more than one component is defective.To address this issue, product quality information pqi_100-169-441 was published on 28.02.2020.During a deeper investigation into generator boards with error e433 it was found that the issue was caused by the defective transformer tr1.An improved generator board was included in the production of the device in mid-july 2020.The corresponding service bulletin sbu_100-184-812_en-ds_00 was published on 04.08.2020.A deeper investigation into hvps-boards with e433 is currently conducted by the r&d department.According to the investigator, an improper handling of the device by the customer cannot be excluded entirely in case of this error pattern.Three attempts were performed to obtain additional information, but no response was received from the customer.Olympus will continue to monitor field performance for this device.

• Brand Name: FOOT SWITCH, SINGLE, FOR, ESG-400
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, deutschland 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: 18257730
• Report Number: 9610773-2023-03498
• Device Sequence Number: 4083099
• Product Code: GEI
• UDI-Device Identifier: 04042761076814
• UDI-Public: 04042761076814
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K203682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024

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
• Operator of Device: Health Professional
• Device Model Number: WB50403W
• Device Lot Number: 13063W130009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2023
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ESG-400.
• Patient Sex: Unknown