MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH BERLIN FACILITY ELECTROSURGICAL GENERATOR "ESG-410"; WA91307W

Model Number	WA91307W
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
It was reported that after use of a resectoscope with electrosurgical generator for transurethral resection (tur) of the prostate or bladder, there was a significant increase in post-operative bleeding requiring surgical revision.It was additionally reported that bleeding usually occurred in the first 2-3 days.The consequence was usually a tur hemostasis with renewed coagulation of the resection areas.The customer reported that the settings were always the same: saline 1 as the recommended default setting and coagulation at 120, effect 2 and there was never an official error message from the device.Attempts to gain amount and severity of bleeding were unsuccessful.Report 1 of 10.
Event or Problem Description
Additional information received from the customer stating that the problem occurred only with this generator.The problem does not occur with the current rental generator and the settings were set to default.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation updated fields: b5, d8, d9, h2,h3, h4, h6 and h11 the device was returned to olympus and the reported failure was not confirmed.As part of the evaluation, the device underwent a visual inspection and functional testing to determine its condition and no problem was detected.Based on the results of the investigation, the definitive root cause of the reported issue could not be determined as no problem was detected with the device.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: ELECTROSURGICAL GENERATOR "ESG-410"
• Common Device Name: WA91307W
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH BERLIN FACILITY; rheinstrasse 8; teltow, brandenburg 14513 ; GM 14513
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH BERLIN FACILITY; rheinstrasse 8; teltow, brandenburg 14513 ; GM 14513
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 24512651
• Report Number: 3003724334-2026-00113
• Device Sequence Number: 13229104
• Product Code: GEI
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2026

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: WA91307W
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/24/2025
• Supplement Date Received by Manufacturer: 06/22/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2020
• 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: RESECTOSCOPE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown