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

Model Number	WB50402W
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reports are being submitted the foot switch and high frequency generator.Please refer to the following events: patient identifier of (b)(6) is related to model number: wb50402w, serial/lot number: unknown.Patient identifier of (b)(6) is related to model number: wb91051w, serial/lot number: (b)(6).This event is under investigation.A supplemental report will be submitted upon receiving additional information.
Event or Problem Description
The customer reported that when using the foot switch, double with the high frequency generator during a procedure, an e433 error message was displayed.The customer noted the foot switch was in bad condition.There was no reported patient harm or impact due to this event.
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 root cause of the event was unable to be identified.The event likely occurred due to the following: 1.A temporarily sticking reed contact.2.A temporary short circuit in the connector plug.3.A temporary short circuit due to moisture-induced leakage currents.Olympus will continue to monitor field performance for this device.

• Brand Name: FOOT SWITCH, DOUBLE, FOR, ESG-400
• Common Device Name: FOOT SWITCH, DOUBLE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17755284
• Report Number: 9610773-2023-02591
• Device Sequence Number: 6618580
• Product Code: GEI
• UDI-Device Identifier: 04042761076807
• UDI-Public: 04042761076807
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/08/2023
• Supplement Date Received by Manufacturer: 01/15/2024
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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