MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMALOOP ¿ SMALL, 30°"; WA47505S

Model Number	WA47505S
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a "tcr" case, the loop of the device broke and fell off inside the body.The fallen pieces were collected by suction.The procedure was completed by replacing it with a similar device without any delay or harm to the patient.
Additional Manufacturer Narrative
D1: full device name: hf-resection electrode "plasmaloop ¿ small, 30°", small loop, 24 fr., 12°-30°, for tcris.The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's (lm) investigation.The device was evaluated by olympus, and the reported failure was confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.Based on the results of the investigation, the reported failure (loop of the device broke/fell inside the body) was likely due to wear and tear and/or mishandling.Moreover, the loop at the distal end of the electrode wears out during use and can break, burn or melt.The event can be detected/prevented by following the instructions for use (ifu) which states: "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: 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." this supplemental report includes an update to h3 from the initial medwatch.Also, information has been added to h4.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE "PLASMALOOP ¿ SMALL, 30°"
• Common Device Name: WA47505S
• 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: 20674396
• Report Number: 9610773-2024-02679
• Device Sequence Number: 8395257
• Product Code: JOS
• UDI-Device Identifier: 14042761085035
• UDI-Public: 14042761085035
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2025

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: WA47505S
• Device Lot Number: 1100432243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TCRIS RESECTOSCOPE: SN UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female