MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH BERLIN FACILITY MULTIPLE; ELECTROSURGICAL GENERATOR

Model Number	WB991036
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, the generator was showing error 231.The issue occurred during preparation for use.There were no reports of patient harm.
Additional Manufacturer Narrative
The evaluation of the event 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 results of the device evaluation, legal manufacturer's final investigation, and information obtained from the customer.Additional information added to the following fields: b5, d8, d9.H3, h4, h6.The device was returned to olympus for evaluation and the customer's reported issue was not confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over six years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be determined as the reported e231 error was not duplicated during the inspection.Possible causes for the error include the following: defective micro controller in the spark monitor (generator board must be replaced).Defective optical transceiver in the spark monitor (generator board must be replaced).Defective optical waveguide.Defective optical transceiver at the control board (control board must be replaced).Defective resistor r28 at the communication board (communication board must be.Replaced).Defective buffer ic3 (control board must be replaced).Defective resistor r28 at the communication board of a connected afu-100 unit.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The intended procedure was diagnostic in nature and completed using a similar device.

• Brand Name: MULTIPLE
• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19342852
• Report Number: 3003724334-2024-00118
• Device Sequence Number: 18314771
• Product Code: GEI
• UDI-Device Identifier: 04042768910364
• UDI-Public: 04042768910364
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K073207
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2024

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: WB991036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2024
• Supplement Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2018
• 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
• Patient Sex: Unknown