MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH NEUTRAL ELECTRODE, UNIVERSAL SIZE, WITHOUT CABLE

Model Number	WA99516A
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, the neutral electrodes does not stick properly and sometimes have to be re-glued with additional plasters.The event was found during the procedure.There were no reports of patient harm.
Additional Manufacturer Narrative
The device was not returned.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Additional information added to fields: b5, h4 and h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.However, the adhesive strength of the neutral electrodes may have been negatively affected due to improper storage.The excessive high temperatures dry out the gel and lead to a loss of adhesive strength.Therefore, the electrode will not be securely attached to the patient's skin.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The event occurred during a polypectomy procedure.  the procedure was completed successfully and without delay.The patient was sedated with propofol, and there were no reports of patient harm.The exact event date was unknown but was approximately mid-february.Related to patient identifier (b)(6).

• Brand Name: NEUTRAL ELECTRODE, UNIVERSAL SIZE, WITHOUT CABLE
• Common Device Name: NEUTRAL ELECTRODE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg/de/germany 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg/de/germany
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18839554
• Report Number: 9610773-2024-00623
• Device Sequence Number: 15324758
• Product Code: GEI
• UDI-Device Identifier: 14042761085875
• UDI-Public: 14042761085875
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2024

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: WA99516A
• Device Lot Number: 337-797
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2024
• Supplement Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown