MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 30°, STERILE, SINGLE USE

Model Number	WA22507D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The referenced device was returned for evaluation and the customer¿s reported issue was confirmed.The loop wire at the distal tip of the electrode was split in the middle, deformed, and broken.The broken end of the loop wire was found melted in spherical shape.Burn marks were observed on the insulation.A review of the manufacturing and quality records for the affected serial number was reviewed without detecting any non-conformities or deviations regarding the described issue.The device history records showed that the device was manufactured according to valid instructions and met all specifications.The investigation is still in progress; however, if additional information becomes available, this report will be supplemented accordingly.In general, the end-user is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.Additional 510(k): k100275.
Event or Problem Description
The customer reported that during a transurethral resection of the prostate procedure, the loop wire at the distal end of the high frequency electrode ¿ruptured on the second approach¿.The intended procedure was completed using a similar device.The device was inspected prior to use with no abnormalities.The customer reported the output settings from the generator machine were unknown.No death or injury and no impact to patient or other has been reported.
Additional Manufacturer Narrative
Corrected fields: d9 (date returned), g2 (added selection and health professional should not be selected on the initial).This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Based on the results of the investigation, the root cause could not be conclusively determined.It is likely the reported event occurred due to the use of excessive force, wrong/improper handling, and/or user error.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 30°, STERILE, SINGLE USE
• Common Device Name: ELECTRODE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 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: 17074145
• Report Number: 9610773-2023-01561
• Device Sequence Number: 6129797
• Product Code: FAS
• UDI-Device Identifier: 14042761068236
• UDI-Public: 14042761068236
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120418
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2023

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: WA22507D
• Device Catalogue Number: WA22507D
• Device Lot Number: 1000101534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2023
• Supplement Date Received by Manufacturer: 09/12/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS: ESG-400 GENERATOR.
• Patient Sex: Unknown