MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH FOOT SWITCH, DOUBLE, FOR, ESG-400; GENERATORS

Model Number	WB50402W
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to olympus, that an hf unit (generator) had an e433 footswitch error.It is unknown, when the reported issue was found.The customer solved the reported issue during troubleshooting.There was no patient injury or adverse event reported to olympus.
Additional Manufacturer Narrative
The device will not be returned to olympus for evaluation, because the issue was resolved.During troubleshooting, the customer was instructed to disconnect the footswitch and the error went away.The customer noticed, the way the cable was wrapped around the footswitch, it was pushing on the pedal.He unwrapped the cable and reconnected the footswitch and tried it again.Olympus will continue to monitor the field performance of this device.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the likely cause of the reported event is due to the cable being wrapped around the foot switch.However, the root cause of the reported information is unable to be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: FOOT SWITCH, DOUBLE, FOR, ESG-400
• Common Device Name: GENERATORS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16942845
• Report Number: 9610773-2023-01336
• Device Sequence Number: 7013113
• Product Code: GEI
• UDI-Device Identifier: 04042761076807
• UDI-Public: 04042761076807
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K203682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2024

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: WB50402W
• Device Catalogue Number: WB50402W
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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: 04/20/2023
• Supplement Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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