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

Model Number	WA47786A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report was not returned to olympus for evaluation.The root cause cannot be determined at this time.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
A user facility reported to olympus that while using the versapoint bipolar electrode resectoscopic - 2.5 mm angled loop, resecting, the distal end of the loop broke in the patient 30 minutes into the procedure.The loop was not found.The procedure continued with a second loop, which also broke.The procedure was then abandoned/interrupted.The patient was given prophylactic antibiotics due to the potential infection risk.It was stated that the physician did not feel there was a risk of uterine perforation or any other serious injury.Additional information was requested, but not provided.This event requires two reports for the two broken loops.Patient identifier's (b)(6).This report is for (b)(6).
Event or Problem Description
It was additionally reported that the procedure was a hysteroscopy and that the patient had a good post surgical recovery.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information obtained from the customer regarding the reported event and investigation results.New information added to the following fields: b1, b5, d4 (expiration date), h4 and h6.The device was not returned for evaluation/investigation.The issue reported by the customer is evaluated as plausible.As part of formal investigation, the root cause for this issue is likely weakness in current material strength and/or ductility.Manufacturing and quality control review was performed for the affected lot or serial number without showing any non-conformities or deviations regarding the described issue(s).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation.The device was returned to olympus for inspection, and the customer's complaint was confirmed.The product was forwarded to the supplier, whom also confirmed the reported issue.The loop at the distal end of the item was broken.The active tip of the device was fractured from the distal tip.No electrical or functional testing was conducted.The condition of the fracture face of the device suggests a brittle failure.The results of the previously reported investigation do not change.Olympus will continue to monitor field performance for this device.

• Brand Name: VERSAPOINT BIPOLAR ELECTRODE RESECTOSCOPIC - 2.5 MM ANGLED LOOP, RESECTING
• Common Device Name: ELECTRODES, PROBES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17090368
• Report Number: 9610773-2023-01592
• Device Sequence Number: 19513867
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/14/2023

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 Catalogue Number: WA47786A
• Device Lot Number: U2209017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2023
• Supplement Date Received by Manufacturer: 06/22/2023; 08/24/2023
• Initial Report FDA Received Date: 06/08/2023
• Supplement Report FDA Received Date: 07/18/2023; 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2022
• 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