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

Model Number	WA91307W
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	Internal Organ Perforation (1987)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the power output was not correct and the patient's bladder was injured.During the cutting process in tur bipolar mode the power output was interrupted.When they restarted the bladder was perforated (occurred 3 times) and new electrodes were used.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Additionally, to provide an update to the initial h3 and to provide a correction to the initial h4.The device was evaluated by olympus, and no reportable malfunctions were found that could have led to the reported event.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, it is likely the reported event occurred due to the following mechanisms caused by the user.1.Incorrect adjustment of the generator, 2.Use of an unsuitable instrument or 3.Unsuitable guidance of the instrument.However, the root cause of the reported event could not be identified with the information received.Olympus will continue to monitor field performance for this device.

• Brand Name: ELECTROSURGICAL GENERATOR "ESG-410"
• Common Device Name: ELECTROSURGICAL SYSTEM GENERATOR
• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19155640
• Report Number: 3003724334-2024-00087
• Device Sequence Number: 20823153
• Product Code: GEI
• UDI-Device Identifier: 04042761086332
• UDI-Public: 04042761086332
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K203277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: WA91307W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2024
• 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: 03/26/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2021
• 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: BIPOLAR RF CABLE, ITEM NUMBER WA00014A.; WA22366A (TRANSPORTER).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown