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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following patient identifiers are linked: (b)(6).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 trans cervical resection in saline procedure, the subject device broke while inside the patient.A medical intervention was done to retrieve the broken part successfully.As the physician was finishing the procedure, the loop broke off again.There was no indication that the second device broke inside the patient.This resulted to a procedural delay of more than 30 minutes.The procedure was then completed with the use of a similar device.There were no further reports of patient harm.
Event or Problem Description
No additional information received from customer.
Additional Manufacturer Narrative
Three attempts were made to obtain additional information, but no response was received from the customer.This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Following field was update: g3, h2, h6, h11.The device did not return to olympus for inspection; therefore, the reported failure was not confirmed.Based on the investigation results, no nonconformances were found related to the reported issue.According to the investigation, the cause of the reported issue could not be established due to no findings available.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• 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: 21031209
• Report Number: 9610773-2024-34349
• Device Sequence Number: 18430645
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2025

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: Health Professional
• Device Model Number: WA47787A
• 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: 11/28/2024
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Female