MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH BERLIN FACILITY ELECTROSURGICAL GENERATOR "ESG-410"; WA91307C

Model Number	WA91307C
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report has been submitted by the importer under this mdr report number 2429304-2024-01003.E2/e3: no information available for the occupation of the initial reporter or whether they are a healthcare professional.The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
During sedation of an unknown therapeutic procedure there was a delay greater than 30 minutes due to the generator displaying an e0728 internal hardware failure error.There were no reports of patient harm.
Event or Problem Description
No additional information received from customer.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Updated fields h2, h6, h11.The device was not returned to olympus for inspection and the reported failure was not confirmed.A root cause could not be identified.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information the updated results of the legal manufacturer¿s investigation updated fields: h2, h3, and h6.Corrections to b1, b2, and h1.This event was initially conservatively reported as a serious injury; however, upon further review, there is no evidence that the patient suffered any serious injury or adverse effects from the prolonged procedure, thus correcting b1, b2, and h1.B1 should not be marked as an adverse event, and b2 should not be marked at all.H1 should also not be marked.The h6 medical device problem reported and other findings would not cause or contribute to a death or a serious injury if it were to recur.The device was returned to olympus for inspection and the reported failure was not confirmed, there is no error present on the device and no additional findings were identified.Based on the updated investigation, and since the device malfunction was not confirmed during evaluation, the definitive root cause of the reported issue could not be determined.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from the customer.

• Brand Name: ELECTROSURGICAL GENERATOR "ESG-410"
• Common Device Name: WA91307C
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH BERLIN FACILITY; rheinstrasse 8; odakura, nishigo-mura,; teltow, brandenburg 14513 ; GM 14513
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH BERLIN FACILITY; rheinstrasse 8; odakura, nishigo-mura,; teltow, brandenburg 14513 ; GM 14513
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20732910
• Report Number: 3003724334-2024-10002
• Device Sequence Number: 21070191
• Product Code: GEI
• UDI-Device Identifier: 04042761086349
• UDI-Public: 04042761086349
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K203277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/30/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: WA91307C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/01/2024
• Supplement Date Received by Manufacturer: 01/09/2025; 11/12/2025
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 02/06/2025; 11/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3002807798-06/04/2024-00
• Patient Sequence Number: 1
• Patient Sex: Unknown