MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH VERSAPOINT BIPOLAR ELECTRODE RESECTOSCOPIC - 2.5 MM ANGLED LOOP, RESECTING; WA47786A

Model Number	WA47786A
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
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 a therapeutic resection of a trophoblastic retention, the loop of the resection device broke.It became stuck in the retention and was recovered under hysteroscopy after a long search.The duration of the operation was extended, with no reports of further patient injury or harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation.Updated fields: d8, d9, h2, h3, h4, h6, h11 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 for inspection and the reported failure was confirmed.The loop of the device had broken off.The broken loop was returned separately.Based on the results of the investigation, the definitive root cause of the loop breakage could not be determined.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from customer.
Event or Problem Description
No additional information received from customer.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide a correction to the h6 investigation conclusion code.

• Brand Name: VERSAPOINT BIPOLAR ELECTRODE RESECTOSCOPIC - 2.5 MM ANGLED LOOP, RESECTING
• Common Device Name: WA47786A
• 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: 21526752
• Report Number: 9610773-2025-01813
• Device Sequence Number: 9560407
• Product Code: HIH
• UDI-Device Identifier: 14042761086254
• UDI-Public: 14042761086254
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K040302
• 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): 06/25/2025

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: WA47786A
• Device Lot Number: 42309104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/04/2025
• Supplement Date Received by Manufacturer: 05/06/2025; 06/23/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 05/27/2025; 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown