MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, ROLLER; ELECTRODES PROBES

Model Number	WA22351C
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	03/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and repair.The investigation is still in progress; therefore, the root cause of the reported defect cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.In general, the customer is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.Olympus will continue to monitor the field performance of this device.Additional pma/510(k): k120418.Model:hf-resection electrode, roller, 24-28 fr., 12° and 30°, sterile, single use, 12 pcs., for turis.
Event or Problem Description
It was reported to olympus that a roller electrode fell off inside the patient during a procedure.The wa22351c was used with an ues-40, for coagulation for quite some time, due to a bladder tamponade.The wire to the roller ball burned through and thereby the ball dropped inside the patient.The ball was retrieved by using optic biopsy forceps and the procedure was only prolonged for about 5-10 minutes.There was no patient injury or adverse event reported to olympus.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information obtained from the customer.Please see update to b5.
Event or Problem Description
Additional information was received from the customer which confirmed the reported event occurred during a therapeutic transurethral resection (tur v) procedure.The patient was under general anesthesia and the procedure was completed using a similar device without delay.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation, the device evaluation, and correction to g2.Please see updates to g2, h3, h6 and h10.The device was returned to olympus for inspection, and the customer's complaint was confirmed.The wire at the distal end is broken on both sides and the roller is detached from the wire.The proximal end does not show any deviation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it¿s likely the device was damaged due to wear and tear.Please note that the loop at the distal end might wear during use and can break, burn or melt.The final root cause of this event was unable to be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE, ROLLER
• Common Device Name: ELECTRODES PROBES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16833600
• Report Number: 9610773-2023-01171
• Device Sequence Number: 11239530
• Product Code: FAS
• UDI-Device Identifier: 14042761051719
• UDI-Public: 14042761051719
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K100275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/21/2023

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: WA22351C
• Device Catalogue Number: WA22351C
• Device Lot Number: 1000105653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2023
• Supplement Date Received by Manufacturer: 05/25/2023; 06/21/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 06/16/2023; 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2022
• 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: ELEMENT WA22366A AND RESECTOSCOPE A22023A/A22041A.
• Patient Sex: Unknown