MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12°-30°, ESG TCRIS; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number	WA47706S
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
Event or Problem Description
The olympus representative reported on behalf of the customer that during a therapeutic hysteroscopic myomectomy, the loop on the hf-resection electrode broke off and needed to be removed by graspers causing the case to be delayed by 25 minutes.The doctor mentioned the loop is flimsy and weak and this is the second loop electrode that has broken on him.The procedure was completed with another device.No patient harm was reported.Related patient identifier: (b)(6) (sn: (b)(6)).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been about 1 year since the subject device was manufactured.Based on the results of the investigation, the cause of the reported issue was likely due to improper handling and/or excessive force by the user.This supplemental report includes information added to h4.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12°-30°, ESG TCRIS
• Common Device Name: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• 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: 17939240
• Report Number: 9610773-2023-02941
• Device Sequence Number: 20528826
• Product Code: FAS
• UDI-Device Identifier: 14042761085530
• UDI-Public: 14042761085530
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K171965
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2024

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: WA47706S
• Device Lot Number: 1000115480
• Was Device Available for Evaluation?: No
• 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: 09/20/2023
• Supplement Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 10/16/2023
• Supplement Report FDA Received Date: 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2023
• 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