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 Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Abnormal Blood Gases (1034); Swelling/ Edema (4577)
Date of Event	07/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the transcervical resection of a fibroid, a significant fluid deficit of approximately 6,200 milliliters (ml) occurred.Initially, fluid input and output were balanced for the first 6 liters; however, mid-procedure, the metal loop of the resectoscope fragmented and became embedded in the fibroid, complicating retrieval and necessitating continuous irrigation with additional fluid sets that were not communicated during the team brief.The number of fluid bags being used was announced, but this was not acknowledged, likely due to the critical focus on locating the missing loop.Because no one was delegated to monitor fluid balance, fluid output was not suctioned or recorded promptly during this period.After retrieving the loop and at the anesthetist's request, a pause was called to calculate fluid balance, revealing that approximately 13,000 ml had been infused with only 6,800 ml accounted for in output, resulting in the deficit.It was noted that the procedure was prolonged by greater than or at least 30 minutes.Edema was noted by the anesthetist, and the surgeon decided to abandon the procedure for patient safety.There were no reports of further patient harm.
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
Upon further follow up by olympus, additional information was received from the customer indicating that the procedure was an elective case and was not done emergently.The patient was under general anesthesia.The fluid used for irrigation was nacl 0.9%.The patient remained hemodynamically stable during the procedure and was noted to be acidotic only on blood gas.The patient was catheterized and kept in overnight with "fluid input/output and monitoring" and responded well without any sequelae.The patient did not undergo another procedure and did not experience any deterioration of their condition from the procedure being abandoned.There was no report of further patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information received from the customer.Updated fields: b2, b5, b6, b7, h6.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation.Updates added to the following fields: d8, d9, h3, h4, h6, h11.The device was returned to olympus for inspection, and the reported failure was confirmed.The loop of the electrode was detached and missing.Based on the results of the investigation, stress problem was identified.However, the most probable cause of the complaint was not established, and the definitive root cause of the reported adverse event could not be determined.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from 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: 22797255
• Report Number: 9610773-2025-05106
• Device Sequence Number: 21000376
• 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): 10/03/2025

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: WA47787A
• Device Lot Number: U2411002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 08/29/2025; 09/17/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 09/19/2025; 10/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2024
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female