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

Model Number	A22251A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Full establishment name: (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, the hf-resection electrode, roller, 24-28 fr., 12° and 30° displayed a bent electrode tip.The issue occurred during preparation for use for a transcervical resection procedure.The procedure was completed using the same set of equipment.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.New information added to the following fields: d8, d9, h3, h4, h6, h11.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over two (2) years since the subject device was manufactured.The device was returned, and an evaluation was completed for it.During inspection, olympus confirmed the reported event.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely that the defect to the product was caused by improper handling during preparation at the customer¿s site or whether there was an undetected fault from the production process.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: 19134392
• Report Number: 9610773-2024-01047
• Device Sequence Number: 4658171
• Product Code: FAS
• UDI-Device Identifier: 04042761021562
• UDI-Public: 04042761021562
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K954488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2024

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: A22251A
• Device Lot Number: 1000094399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/17/2024
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown