MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH VERSAPOINT II BIPOLAR ELECTRODE RESECTOSCOPIC - 4.0 MM ANGLED LOOP, RESECTING; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE-USE

Model Number	WA47787A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported that during an unknown procedure, the tip of the electrode was detached.The patient underwent an ultrasound procedure to locate the tip which was then removed with another operation.The procedure has been completed using a similar device.There were no further reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation, the legal manufacturer's final investigation updated fields: d8, d9 date returned to mfg, h2, h3, h4, h6 (type of investigation, investigation findings and investigation conclusions) and h11.The device was not returned to olympus for inspection and the reported failure was not confirmed.Based on the results of the investigation, and since the device malfunction was not confirmed during evaluation, the definitive root cause of the reported issue could not be determined.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
No additional information received form the customer.
Event or Problem Description
This mdr is being submitted to provide a correction to d2a - common device name.The correct input for this field is: endoscopic electrosurgical electrode, bipolar, single-use.
Additional Manufacturer Narrative
This mdr is being submitted to provide a correction to d2a - common device name.The correct input for this field is: endoscopic electrosurgical electrode, bipolar, single-use.

• Brand Name: VERSAPOINT II BIPOLAR ELECTRODE RESECTOSCOPIC - 4.0 MM ANGLED LOOP, RESECTING
• Common Device Name: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE-USE
• 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: 21338248
• Report Number: 9610773-2025-00949
• Device Sequence Number: 15591089
• Product Code: HIN
• UDI-Device Identifier: 14042761086261
• UDI-Public: 14042761086261
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K111751
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: WA47787A
• Device Lot Number: U2402060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/10/2025
• Supplement Date Received by Manufacturer: 05/06/2025; 02/12/2026
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 05/09/2025; 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown