MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, LARGE, 24 FR., 12°-30°, ESG TURIS; WA22707S

Model Number	WA22707S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the event is still on-going.Should additional information be received, a supplemental report will be provided.
Event or Problem Description
The customer reported that an olympus hf resection electrode broke when used during a procedure.The customer confirmed that no further information was available concerning this event.However, there was no patient harm reported as a result of this event.
Additional Manufacturer Narrative
This report is being submitted to capture additional event/patient information provided from the initial reporter.That information is documented in section b.Should additional information be received; another supplemental report will be provided.
Event or Problem Description
Additional information was received from the initial reporter confirming an event date of august 10, 2024.The initial reporter went on to note that the procedure had not yet commenced as the loops broke during preparation.Reportedly, the intended procedure was confirmed completed without patient harm or delay.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's 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, as the device was discarded by the facility, the root cause of the reported event is unable to be determined.However, the likely cause of the reported event is due to wrong handling by preparation on pre the procedure.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, LARGE, 24 FR., 12°-30°, ESG TURIS
• Common Device Name: WA22707S
• 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: 20522617
• Report Number: 9610773-2024-02573
• Device Sequence Number: 7969346
• Product Code: FAS
• UDI-Device Identifier: 14042761085363
• UDI-Public: 14042761085363
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K171965
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/03/2024

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: WA22707S
• Device Lot Number: 1000148178
• 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: 10/13/2024
• Supplement Date Received by Manufacturer: 10/30/2024; 11/28/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 10/30/2024; 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2024
• 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