MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, ROLLER, 24-28 FR., 12° AND 30°

Model Number	WA22351C
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1 establishment name (documented here in its entirety due to character limitations in respective field): (b)(6) hospital.The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that during an unspecified procedure, the tip roller of the subject device fell off.The procedure was completed without retrieving the fallen tip.There have been no reports of health problems from this incident.Additional information has been requested but no further details have been provided at this time.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, it is likely that the reported event occurred due to wear and tear and/or wrong handling.Additionally, the tip at the distal end wears out and may burn or melt if broken.However, the subject device was not returned, and the root cause of the reported event could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE, ROLLER, 24-28 FR., 12° AND 30°
• 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: 20623423
• Report Number: 9610773-2024-02656
• Device Sequence Number: 8905972
• Product Code: FAS
• UDI-Device Identifier: 14042761051719
• UDI-Public: 14042761051719
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2025

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: WA22351C
• Was Device Available for Evaluation?: No
• 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: 10/17/2024
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: WA22367A (RIGID ENDOSCOPE WORKING GUIDE)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown