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

Model Number	WA91307C
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned and evaluated, and the customer¿s allegation (error code 1010) was confirmed.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.This report has been submitted by the importer under this mdr report number 2429304-2023-00313.
Event or Problem Description
An olympus representative reported, on behalf of the customer, there was an error code 1010 displayed and the device would shut down when using an electrosurgical generator "esg-410".The event occurred during the therapeutic procedure (transurethral resection of bladder tumor-turbt) which led to the case being aborted.There was no patient harm associated with the event.
Additional Manufacturer Narrative
This report is being supplemented to provide a correction to the h10 field.
Additional Manufacturer Narrative
This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is (b)(4).
Additional 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.It has been over 1 year since the subject device was manufactured.Based on the results of the investigation, it was determined that the reported event (error message/device shut down resulting in aborted procedure) was likely caused by the following: 1.Flexray fpga (pcba flexray fpga) cannot be programmed.2.Ultrasonic fpga (pcba surgisaber) cannot be programmed.3.Defect of the cpu module (pcba control) or wiring board (pcba wiring).The event can be detected/prevented by following the instructions for use (ifu) which state: ¿a suitable replacement device must be provided during an application.¿ olympus will continue to monitor field performance for this device.

• Brand Name: ELECTROSURGICAL GENERATOR "ESG-410"
• Common Device Name: ELECTROSURGICAL 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 14513 ; GM 14513
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17881621
• Report Number: 9610773-2023-02824
• Device Sequence Number: 15396166
• Product Code: GEI
• UDI-Device Identifier: 04042761086349
• UDI-Public: 04042761086349
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/01/2024

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: WA91307C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2023
• 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: 09/08/2023
• Supplement Date Received by Manufacturer: 06/17/2024; 06/21/2024; 07/01/2024
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 06/18/2024; 06/26/2024; 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2023
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown