MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, LARGE, 24 FR., 12°-30°, ESG TURIS; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE-USE

Model Number	WA22707S
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and evaluated.The electrode was also returned with the hf-cable.The customer¿s allegation was confirmed due to the loop and forks being severely bent.The distal end loop was observed under a microscope and the loop had no signs of char marks or missing portions.The insulation on the deformed forks have no indications of melted or damaged insulation.The shaft appeared to be normal as no excessive kinks or bends were noticed.The proximal end appeared to be normal as no damages was present.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
An olympus representative reported on behalf of the customer that when using a high-frequency resection electrode plasma loop, the fork tubes at the distal end of the electrode were bent.The event occurred prior to the intended procedure.There was no patient harm associated with the event.
Event or Problem Description
The therapeutic procedure (transurethral resection of bladder tumor) was completed with the same device.There was a minor delay of a couple of minutes.No additional treatment was required.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information obtained from the customer and results the approved final investigation.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, the root cause of the damaged loop could not be identified.It was unclear whether there was an undiscovered production defect or the damage to the product was caused when it was removed from the blister or when it was mounted in the resectoscope.The issue is addressed in the instructions for use (ifu): ¿bending the distal tip may damage the hf-resection electrode leading to sparkover between the hf-resection electrode and the telescope.There is a risk of electrical, mechanical and thermal injury and/or unintended nerve stimulation.¿ ¿never try to bend the distal tip of the hf-resection electrode.¿ olympus will continue to monitor the field performance of this device.

• Brand Name: HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, LARGE, 24 FR., 12°-30°, ESG TURIS
• Common Device Name: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE-USE
• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16729103
• Report Number: 9610773-2023-01024
• Device Sequence Number: 17737097
• Product Code: FAS
• UDI-Device Identifier: 14042761085363
• UDI-Public: 14042761085363
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2023

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 Expiration Date: 07/21/2026
• Device Model Number: WA22707S
• Device Catalogue Number: WA22707S
• Device Lot Number: 1000082171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2023
• 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: 03/13/2023
• Supplement Date Received by Manufacturer: 06/05/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2021
• 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: Unknown