MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH VERSAPOINT BIPOLAR ELECTRODE - SPRING TIP, 5 FR. (1.6 MM NOM.) X 360 MM

Model Number	WA47783A
Medical Device Problem Codes	Degraded (1153); Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: component failure.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The versapoint bipolar electrode was returned to the service center with a report of damaged versapoint electrode.This does not indicate an mdr reportable event.However, mdr reportable failure was found during testing at the service center.During inspection of the device, the spring tip detached/broken off/damage and there was evidence of charred marks with the electrode tip was identified.There was no patient involvement.

• Brand Name: VERSAPOINT BIPOLAR ELECTRODE - SPRING TIP, 5 FR. (1.6 MM NOM.) X 360 MM
• Common Device Name: VERSAPOINT BIPOLAR ELECTRODE
• 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 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 25302947
• Report Number: 9610773-2026-04102
• Device Sequence Number: 9319700
• Product Code: HIH
• UDI-Device Identifier: 14042761086223
• UDI-Public: 14042761086223
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K962482
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/27/2026

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: Other
• Device Model Number: WA47783A
• Device Lot Number: U2303093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown