MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH CABLE, FOR NEUTRAL ELECTRODE; ELECTRODE CABLE

Model Number	WA99510A
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is provided.
Event or Problem Description
The customer reported that during a polypectomy the blue pedal and generator did not work.The procedure was completed using a similar device and no delay was reported.There were no reports of harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was returned to olympus and evaluated, and the reported phenomenon blue pedal and generator not working was not confirmed.Since no malfunction of the cable is identified, no technical cause for the reported issue can be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: CABLE, FOR NEUTRAL ELECTRODE
• Common Device Name: ELECTRODE CABLE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18088295
• Report Number: 9610773-2023-03207
• Device Sequence Number: 6254242
• Product Code: GEI
• UDI-Device Identifier: 04042761085892
• UDI-Public: 04042761085892
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K173877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2023

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: WA99510A
• Device Lot Number: 148/546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2023
• 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: 10/11/2023
• Supplement Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 11/07/2023
• Supplement Report FDA Received Date: 12/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2021
• 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: ESG-100
• Patient Sex: Unknown