MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 12°

Model Number	WA22503D
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, the high frequency-resection electrode, was not working as it was not coagulating.The doctor found out the loop was broken and replaced the loop with an electrode roller ball.While doing the replacement, an attempt was made to remove the loop, and it was evident that the electrode has melted and was stuck.The electrode loop was pulled out using force.The issue occurred during a diagnostic procedure for a hysteroscopic transcervical resection of myoma (tcrm) and lap myomectomy.The procedure was completed with no reports of patient harm or injury.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.New information added: d9, h3,h4, h6.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 was confirmed that the hf-resection electrode¿s distal end loop was melted and broken.Furthermore, the electrode was bent approximately 6 cm towards the distal end.The loop wire is broken and has melted into the spherical balls.Furthermore, the proximal end was deformed, and the electrode guide tube was torn from the electrode.This damage was caused during electrode replacement and was probably due to improper unlocking of the electrode, i.E.Not pressing the release button on the working element.This type of damage is caused by the possibility of plasma ignition even if the loop wire is broken, so that the user may continue to resect the tissue during the procedure until the damage at the distal end is visually detected.Or, as in this case, although the damage at the distal end (fracture / melted spherical drops, melting of the insulating tubing and deformation of the wire ends) had to be recognizable, tissue was continued to be resected.The reported issue and damage are attributed to user error, wrong handling and application of excessive force.Depending on the status of the ifu, two additional cautions have been communicated through the leaflet: caution 1: "caution risk of injury to the patient contact between the hf-resection electrode and metal parts, such as other endoscopic equipment, implants or stents can result in sparkover between the hf-resection electrode and the metal part.Always keep a distance of at least 10 mm between the hf-resection electrode and metal parts." caution 2: "caution risk of injury to the patient use extreme caution when using electrosurgery in close proximity to or in direct contact with any metal objects.Do not activate the hf-resection electrode while any portion of the hf-resection electrode tip is in contact with another metal object.This can cause uncontrolled heating of the hf-resection electrode and may result in damage and breakage to the hf-resection electrode tip.If excessive heating or physical forces cause damage to the hf-resection electrode tip, broken device fragments may remain in the body, possibly requiring additional surgery for removal.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 12°
• Common Device Name: HF-RESECTION ELECTRODE
• 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: 18991073
• Report Number: 9610773-2024-00888
• Device Sequence Number: 7605675
• Product Code: FAS
• UDI-Device Identifier: 14042761068205
• UDI-Public: 14042761068205
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2024

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: WA22503D
• Device Lot Number: 1000128114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/18/2024
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2023
• 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
• Patient Sex: Unknown