MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH VERSAPOINT II BIPOLAR ELECTRODE RESECTOSCOPIC - 4.0 MM ANGLED LOOP, RESECTING; WA47787A

Model Number	WA47787A
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a therapeutic transcervical resection of a fibroid, the loop of the suspect device broke off in the patient and was unable to be retrieved.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Additional Manufacturer Narrative
Update to b2, b5, h6.This report is being supplemented to provide additional information based on the approved final investigation.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.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The loop of the suspect device broke off and fell within the uterine cavity.The patient underwent x-ray imaging and hysteroscopy post procedure, however the fragment was not visible despite thorough examination.As the patient was asymptomatic, she was offered the option of a repeat hysteroscopy with transcervical resection of the fibroid remnant, or expectant management, and chose expectant management.A repeat abdominal x-ray and follow up will be conducted.
Additional Manufacturer Narrative
This supplemental emdr is being submitted to correct coding.If additional information becomes available an emdr supplement will be submitted.
Event or Problem Description
No additional information was received from the customer.

• Brand Name: VERSAPOINT II BIPOLAR ELECTRODE RESECTOSCOPIC - 4.0 MM ANGLED LOOP, RESECTING
• Common Device Name: WA47787A
• 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: 23468628
• Report Number: 9610773-2025-06826
• Device Sequence Number: 18376588
• Product Code: HIN
• UDI-Device Identifier: 14042761086261
• UDI-Public: 14042761086261
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/02/2026

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: U2501002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 11/14/2025; 01/22/2026
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 12/04/2025; 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/14/2025
• 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: Female